fda lcd monitors for import price

Today, modern computers displays and televisions (TVs) today use liquid crystal display (LCD), Light-emitting diodes (LED), plasma, or other technologies that do not contain cathode ray tubes (CRTs).

A CRT is a specialized vacuum tube that can be used to receive and display images on an electronic screen. In the early 1960s, some TVs with CRTs were found to emit excessive x-radiation, and a federal performance standard was created to protect the public from this hazard. In the years that followed, the electronic technology for TVs and computer monitors with CRTs changed so drastically that the level of risk of x-ray exposure became almost non-existent. Manufacturers of products that still use CRTs must certify that their products comply with the federal performance standard for the life of the product.

Modern TV receivers and computer monitors provide a benefit for entertainment and information display in many settings. TV receivers and computer monitors containing CRTs no longer pose a risk of emitting any x-radiation. Since the creation of the federal performance standard, the FDA has tested hundreds of TV receivers and computer monitors and rarely encountered any that were unsafe. Most modern computer monitors and televisions (TVs) today use liquid crystal display (LCD), Light-emitting diodes (LED), or plasma and do not contain CRTs or emit x-radiation.

Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic (FD&C) Act, Chapter V, Subchapter C - Electronic Product Radiation Control.

Manufacturers of televisions and video display products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:

In addition, TV receivers and monitors with CRTs must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1020:

This guidance document is a restatement of the Food and Drug Administration’s (FDA"s) current requirements for prior notice of food presented in simplified format and language. As guidance, it is not binding on either FDA or the public. FDA notes, however, that the regulation that is the basis for this pamphlet establishes requirements for all covered activities. For this reason, FDA strongly recommends that affected parties consult the regulation at 21 CFR Part 1, Subpart I, in addition to reading this pamphlet.

The Food and Drug Administration has prepared this guidance to restate the legal requirements set forth in 21 CFR 1.276 through 1.285 concerning prior notice of imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This guide is intended to help any entity, regardless of size, to comply with the regulations that require the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. This document also serves as FDA’s Small Entity Compliance Guide (SECG), in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply or other food-related emergencies.

To carry out the provisions of the Bioterrorism Act, FDA issued a final regulation amending the existing requirements in 21 CFR Part 1, Subpart I, which requires that FDA be given advance notice on shipments of imported food.

An amendment to the regulations was also made as required by the FDA Food Safety Modernization Act (FSMA).  An interim final rule went into effect July 3, 2011 that requires an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing the potential risks of food imported into the United States.

This booklet was created to inform food transporters, food importers and exporters, foreign manufacturers and growers, and food filers and brokers about the prior notice requirements, as amended. It contains important information that may affect your food imports.

As of December 12, 2003, FDA must be notified in advance of any shipments of food for humans and other animals that are imported into the U.S., unless the food is exempt from Prior Notice.

On October 10, 2003, the Secretaries of the Departments of Health and Human Services (HHS) and Homeland Security (DHS) jointly published an interim final rule (2003 IFR) to implement prior notice. The 2003 IFR took effect on December 12, 2003, as required by the Bioterrorism Act; however, FDA and the U.S. Customs and Border Protection (CBP) gave interested persons 165 days to comment on the provisions of the 2003 IFR that we would consider as we developed the final rule. The final rule, which took effect on May 6, 2009, maintains the majority of the requirements found in the 2003 IFR and includes revisions in a few key areas.

To assist importers, the final rule now permits prior notice submissions to be submitted no more than 15 calendar days before the anticipated date of arrival for submissions made through FDA"s Prior Notice System Interface (PNSI) and no more than 30 calendar days before the anticipated date of arrival for submission made through CBP"s Automated Broker Interface of the Automated Commercial System (ABI/ACS), instead of the 5 calendar days required in the 2003 IFR.

The final rule adds a definition for "manufacturer" as the last facility, as that word is defined in 21 CFR 1.227(b)(2), that manufactured/processed the food and provides an alternative for identifying the manufacturer when the registration number is not provided such as when it is not known.

The final rule allows, when certain conditions are met, for the submission of the express consignment operator or carrier tracking number in lieu of the anticipated arrival information, Bill of Lading, or Airway Bill number and flight number, which the IFR required.

FDA issued an interim final rule (2011 IFR) to require that additional information be provided in a prior notice of imported food submitted to FDA. Specifically, the 2011 IFR requires a person submitting prior notice of imported food, including food for animals, to report, in addition to other information already required, “any country to which the article has been refused entry.” The 2011 IFR, which took effect July 3, 2011, implements section 304 of the Food Safety Modernization Act.

The following chart lists food imports that require Prior Notice. If the food you are importing falls under one of these requirements, be sure to review the Exemptions box (on the following page) to see whether any exemptions apply.

Food imported for use, storage, or distribution in the U.S. (including gifts and trade and quality assurance/quality control and market research samples)

The following chart lists exemptions from the Prior Notice rule.  If any of these exemptions apply to a food shipment you are importing, you do NOT have to submit Prior Notice for that shipment.

Food carried by or otherwise accompanying (e.g., baggage) an individual arriving in the U.S. for that individual"s personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution)

Food made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the U.S.

Meat food products, poultry products, and egg products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act

Any individual with knowledge of the required information can submit Prior Notice.  This includes individuals, manufacturers, exporters, brokers, importers, and U.S. agents.

Food that is imported or offered for import with inadequate Prior Notice is subject to refusal and, if refused, must be held at the port of entry unless directed to another location. The importing or offering for import into the U.S. of an article of food in violation of Prior Notice requirements is a "Prohibited Act" under the laws FDA administers. FDA has provided its staff with enforcement guidance containing the agency"s policies on refusals, holds, injunctions, prosecution, and debarment related to failure to provide timely and accurate Prior Notice or otherwise comply with FDA Prior Notice regulations.

The FDA Prior Notice System Interface (PNSI) is available 24 hours a day, 7 days a week.  FDA’s and CBP’s computer systems enable you to submit Prior Notice as part of the entry process. This will avoid duplication of information.

If a broker"s or filer"s Automated Broker Interface (ABI) system or the ABI/Automated Commercial System (ACS) interface is not operating, Prior Notice must be submitted through the FDA Prior Notice System Interface.

If the FDA PNSI is not operating, or if the Operational and Administrative System for Import Support (OASIS) is not operating, FDA will post prominent notification and instructions on the System Status web page. FDA will accept Prior Notice submissions in the format it deems appropriate during the system(s) outage.

FDA must electronically receive and confirm Prior Notice before a food shipment arrives at the first port in the United States (port of arrival). The deadline for submitting Prior Notice depends on the mode of transportation used for shipment.

Except in the case of food arriving by international mail, FDA must receive and confirm a Prior Notice: 1) no more than 30 days before a shipment arrives, if Prior Notice is submitted via ABI/ACS; or 2) no more than 15 days before a shipment arrives, if Prior Notice is submitted via FDA’s PNSI.

Note: Unless the Prior Notice is for food arriving by international mail or is carried by or otherwise accompanies an individual, Prior Notice submitted by ABI/ACS does not require additional documentation (although it may be prudent for the carrier to have a copy of Prior Notice confirmation or the associated entry number in his/her possession when arriving at the port of arrival).

FDA offers an online tutorial on how to use the FDA Prior Notice System Interface. The FDA PNSI has Help features and interactive feedback to assist the submitter and minimize spelling mistakes and omissions. In addition, FDA has two offices that can provide assistance with Prior Notice:

Importers or brokers already provide most of the information required for Prior Notice to CBP when goods arrive in the U.S. According to the Bioterrorism Act, FDA must receive the required information before a shipment of food arrives.

If the food is no longer in its natural state: manufacturer’s name and either 1) the registration number, city, and country of the manufacturer, or 2) both the full address of the manufacturer and the reason the registration number is not provided (reasons listed in the Compliance Policy Guide for Prior Notice of Imported Food)

Country from which food is shipped; or, if food is imported by international mail, the anticipated date of mailing and country from which food is mailed

Name and full address of importer, owner, and consignee, unless the shipment is imported or offered for import for transshipment through the U.S. under a transportation and exportation (T&E) entry; or, if food is imported by international mail, the U.S. recipient’s name and address

Both the ABI/ACS and the PNSI review the Prior Notice information you submit and provide feedback to help minimize errors. During submission, if information is missing or appears to be incorrect, or if there appear to be typographical errors, the system will give you an opportunity to make corrections electronically.

Once you submit all of the required Prior Notice information, you will receive confirmation, including a confirmation number, from FDA directly or from FDA through CBP’s ABI/ACS.

Note: This confirmation means that FDA has deemed your Prior Notice facially complete. The confirmation does NOT mean that FDA has determined your Prior Notice is accurate, that FDA has approved the shipment, or that FDA has determined that the shipment may proceed without further FDA action. Subsequent system review and review by FDA staff may result in inspection of the imported food shipment upon arrival, or other action.

If Prior Notice was submitted through the FDA PNSI, the carrier must have the Prior Notice confirmation number. In other cases, it is prudent for the carrier to have a copy of Prior Notice confirmation or the confirmation number in his/her possession when arriving at the port of arrival.

FDA must have adequate time to receive, review, and respond to each Prior Notice submission.  Therefore, you cannot amend or change Prior Notice information once FDA has confirmed it. Instead, if any of the information in the following table changes, you must submit a new Prior Notice.

If the food is no longer in its natural state: manufacturer’s name and either 1) the registration number, city, and country of the manufacturer, or 2) both the full address of the manufacturer and the reason they registration number is not provided (reasons listed in the Compliance Policy Guide for Prior Notice of Imported Food)

Country from which food is shipped; or, if food is imported by international mail, the anticipated date of mailing and country from which food is mailed

Name and full address of importer, owner, and consignee, unless the shipment is imported or offered for import for transshipment through the U.S. under a T&E entry; or, if food is imported by international mail, the U.S. recipient’s name and address

WHAT It Is: As of December 12, 2003, FDA must be notified in advance of any shipments of food for humans and other animals that are imported into the U.S., unless the food is exempt from Prior Notice.

Articles used for food or drink for man or other animals; chewing gum; and articles used for components of any such articles (excluding food contact substances and pesticides).

If the food is no longer in its natural state: manufacturer’s name and either 1) the registration number, city, and country of the manufacturer, or 2) both the full address of the manufacturer and the reason the registration number is not provided (reasons listed in the Compliance Policy Guide for Prior Notice of Imported Food)

Country from which the food is shipped or, if the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed

Name and full address of importer, owner, and consignee, unless the shipment is imported or offered for import for transshipment through the U.S. under a T&E entry; or, if the food is imported by international mail, the U.S. recipient’s name and address)

Food carried by or otherwise accompanying (e.g., baggage) an individual arriving in the U.S. for that individual"s personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution)

Food made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the U.S.

Meat food products, poultry products, and egg products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act

WHO Can Give Prior Notice:Any individual with knowledge of the required information — including manufacturers, exporters, brokers, importers, and U.S. agents.

WHEN to Give Prior Notice:Except in the case of food arriving by international mail, FDA must receive and confirm a Prior Notice: 1) no more than 30 days before a shipment arrives, if Prior Notice is submitted via ABI/ACS; or 2) no more than 15 days before a shipment arrives, if Prior Notice is submitted via FDA’s PNSI.

ACS Transmission: Contact your CBP client representative.PNSI Transmission: FDA offers an online tutorial on how to use the FDA Prior Notice System Interface. The FDA Prior Notice System Interface has Help features and interactive feedback to assist the submitter and minimize spelling mistakes and omissions. In addition FDA has two offices that provide assistance with Prior Notice:

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If you are planning on importing any device that is or consists of a tablet or a display screen, take heed of regulatory obstacles that might stand in your way.  Since both tablets and display screens often emit radio noise and small amounts of radiation, these devices must comply with Federal Communications Commission (FCC) and the Federal Drug Administration (FDA) standards.  In other words, all screen and tablet importers must be certified under both government bodies before importing their products.

The first step, however, is to determine the official classification of your tablet or display screen.  The Harmonized Tariff Schedule is the database to find the customs duties that will apply to your product.  Below are some tips on how to import your tablet or screen in accordance with FCC and FDA regulations and standards:

Since tablets are distributed for consumer use, they fall under FCC Class B categorization. Tablets and screens are classified as “non-licensed, low-power transmitters,” and fortunately consumers do not need a license from the FCC to use them. However, those importing them will need to get them FCC-certified for safety.

To obtain FCC certification for a product, you need to submit the device for testing at an FCC-authorized lab.  Then, the product must be tagged with a compliance label along with an FCC ID (which can be created with a grantee code and a product code).  Finally, you can submit the testing results and device specifications, along with the proper labels, to the FCC for approval and they will send you a grant of certification.

Tablets and screens also fall under FDA regulation since they include lasers, LED, or Intense Pulsed Lights, which emit potentially harmful radiation.  While the FDA does not technically need to grant approval for products, they do have the right to ban products or order for changes in a device if they do not meet FDA standards.  For this reason, importers or manufacturers need to test and certify a product themselves to meet those standards.  However, though products are not officially FDA approved, some products – such as medical devices – will require importers to submit reports, which can be done electronically at the FDA’s eSubmitter site.  Only after the submission is received will the FDA issue an accession number, which will certify that the product can be marketed commercially.

Importers will also be required to submit a Form FDA 2877 with the accession number and the importing paperwork to Customs and the FDA imports office when their shipment enters the US.  As long as the products are labeled and certified properly and the paperwork is in good order, the importing process will go smoothly.

Dental chair packages or dental operatory packages are high-ticket items that should be carefully considered. These dental operatory packages can include everything a dentist will need for dental procedures. Included may be: dental chair, dentist stool, assistant stool, dental delivery system and lighting. Choosing to purchase a dental operatory package versus purchasing the components separately can be beneficial in that you are assured that everything will integrate seamlessly and if problems arise there is only one vendor to contact. The dental chair included in the package should be ergonomic, fully adjustable and have a thin backrest for adequate legroom. The dental delivery system that is included in dental chair packages often includes asepsis automatic control for handpieces, purge system and self-contained water system. Various modules like intraoral cameras, x-ray viewers, LCD monitors can also be integrated into dental operatory packages. Some high-end dental chair packages even boast high quality materials and have a modern sophisticated design. Regardless of which dental operatory package chosen for your practice, research the product and the vendor and be sure reliable customer service is present.

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This guide serves as an ongoing report of the most recent FDA inspection and enforcement trends, specifically in the area of good manufacturing practice (GMP), based on publicly available data. We"ve included a mix of our firsthand research along with others" analyses and links to the appropriate sources.

Note that the data presented here conform to the fiscal year accounting period for the federal government, which begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends.

In November 2022, Jeffrey Meng, program division director, Division of Pharmaceutical Quality Operations III, Office of Regulatory Affairs, stated that the backlog of foreign and domestic onsite inspections for sites considered a high priority. "Looking forward to 2023 and beyond, we have resumed all routine domestic operations and are currently resuming normal foreign inspections. This opening of worldwide operations for FDA will be and is an incredible challenge.” (RAPS)

The number of domestic FDA inspections related to drugs rose from 713 in FY2021 to 756 in FY2022, a ~6% increase. The number of foreign FDA inspections related to drugs rose from 130 in FY2021 to 262 in FY2022, a ~101% increase. (FDA data dashboard)

The number of domestic FDA inspections related to devices rose from 382 in FY2021 to 935 in FY2022, a ~144% increase. The number of foreign FDA inspections related to devices rose from only 4 in FY2021 to 79 in FY2022, a whopping 1875% increase. (FDA data dashboard)

For example, not all inspections are included in the database. Inspections conducted by states, pre-approval inspections, mammography facility inspections, inspections waiting for a final enforcement action, and inspections of nonclinical labs are not included.

#4 —21 CFR 211.100(a) — There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess...

#6 — 21 CFR 211.67(b)— Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product...

#7 — 21 CFR 211.25(a) — Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions...

#9 — 21 CFR 211.67(a) — Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

#10 — 21 CFR 211.110(a) — To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product...

Given that FDA"s inspectional citations specify different descriptions and particular subparts, the interactive chart below breaks down these details to show the relative prevalence of certain observed issues over others.

— Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

#4 —21 CFR 820.90(a) — Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements...

— Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established...

Given that FDA"s inspectional citations specify different descriptions and particular subparts, the interactive chart below breaks down these details to show the relative prevalence of certain observed issues over others.

In 2022, the Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research (CDER) published its fiscal year 2021 report on the state of pharmaceutical quality. We distilled some of its main takeaways below.

OPQ said its New Inspection Protocol Project (NIPP) program has increased the efficiency of inspections through a more targeted and data-driven approach to identify potential quality problems early on. FDA says its NIPP has “improved how data from pre-approval and surveillance inspections are evaluated and reported.” (FDA has been using these inspection protocols for certain sterile surveillance and pre-approval inspections since 2018.)

Sites making “essential medicines” that protect the public against outbreaks of emerging diseases such as COVID-19 have high median site inspection scores (SIS), indicating a high rate of compliance with GMP. An analysis of active pharmaceutical ingredient (API) and finished dosage form (FDF) sites found that the median SIS for essential medicine manufacturers was 7.45 out of 10, a score that was “significantly higher” than the 7.0 score for non-essential medicine manufacturers. “This observation indicates that sites manufacturing EM products have a higher level of adherence to manufacturing compliance standards than sites that do not manufacture EM products,” OPQ wrote.

For the second year, the number of total recalls (particularly Class I recalls) has increased. This follows a three-year period of declining recalls from FY2017 to FY2019. Since FY2016, recalls spiked up dramatically, going from roughly 300 recalls events a year in 2019 to 700 in FY2020 to 800 in FY2021. Hand sanitizers that contained methanol, as well as consumer products and sunscreens with benzene contamination are largely to blame for the increase.

Roughly half (49.1%) of 1,143 eligible firms did not submit field alert reports (FARs) to the agency over a four-year period from FY2018 to FY2021. FDA’s postmarket reporting requirements specify that sites submit FARs after receiving information on significant quality problems with their distributed drug products.

A growing number of products are failing sampling and testing requirements; a method of inspection is used when FDA cannot get to sites to conduct inspections. In FY2021, the percentage of non-compliant samples grew to 35%, an increase from 16% in FY2020. The growing rate of non-compliance “is driven by focused sampling assignments with high non-compliant rates for products with nitrosamine contamination, hand sanitizers, and sampling related to COVID-19 mission critical sampling and testing, which became more prominent in FY2021.“

Read FDA"s full FY2022 report (PDF) on fda.govhere. We distilled some of its main takeaways below. Read our blog post for more depth into some of these takeaways.

FDA used Mutual Recognition Agreements (MRAs) and its authority to obtain records for sites in advance or in lieu of inspections due to the pandemic.In 2012, the Food and Drug Administration Safety and Innovation Act gave FDA new authorities under the Food, Drug, and Cosmetic Act §704(a)(4) to request records or other information from firms in advance of or in lieu of an inspection.

“FDA surveillance history, requests for records, and inspection reports obtained through the MRAs were all used to mitigate risk and enable regulatory actions.”

“MRA authority was used to assess 183 sites through MRA inspection reports for a total of 745 sites (18% of the FY2020 CDER Site Catalog). For comparison, in FY2019 1,258 drug quality assurance inspections were performed and an additional 109 sites were assessed using MRAs for a total of 1,367 sites (32% of the FY2020 CDER Site Catalog).”

“As in past years, the majority of Warning Letters in FY2020 were issued to sites with non-application products (69%), and especially those that manufacture finished dosage form (FDF), non-sterile, non-application products (41% of all Warning Letters).”

“Import Alerts doubled to 128 in FY2020. Latin America had the most sites on Import Alert for the first time in FY2020, due to an unprecedented number of new hand sanitizer registrants from Mexico that failed to meet quality standards."

Since FY2019, there has been a small decrease (0.10) in the mean Site Inspection Score (SIS) of the entire inventory of sites (7.3).FDA’s SIS, a scale of 1 to 10, is used as a proxy for compliance with CGMP regulations. The SIS is based on the classification of FDA drug quality assurance inspections conducted over the prior ten years, including inspections classified under the MRA program, which allows some global regulators to recognize reports from their counterparts’ inspections.

“For FY2016–FY2020, three defect categories account for 60% of all defects reported: Product Quality Questioned, Device Issues, and Packaging Issues.”

“The most substantial increases in the number of recalls by industry sector in FY2020 were in the No Application and NDA & ANDA (i.e., sites manufacturing for both application types) sectors.” (See full report for additional details.)

“Each major recall over the last five fiscal years was associated with microbial or chemical contamination/impurities; a focus area for the industry to improve quality.”

CDER will continue to seek to minimize long-standing problems such as drug shortages due to quality issues through proactive efforts including the New Inspection Protocol Project (NIPP) and Quality Management Maturity. The NIPP “is aimed at using standardized electronic inspection protocols to collect data in a structured manner. The protocols promote consistent and comprehensive coverage of critical areas of drug manufacturing and provide structured, data-rich reports.

“In the future, FDA will have the ability to better understand how certain variables (e.g., location of the establishment, type of establishment) affect quality. As more data are collected through NIPP, these types of insights can inform future inspections, identify policy/outreach opportunities, and influence application-related decision making."

A report published by the ECA Academy looked back from October 2018 to September 2019 to review the FDA warning letter trends among pharmaceutical manufacturers.

Where applicable, we’ve provided links to relevant resources and next steps for those looking for guidance and assistance in mitigating trending risks.

The specific issues contained within these recent warning letters reveal a continuation of a trend that’s been running for years: lapses in meeting basic GMP requirements.

As analyzed and compiled by Barbara Unger in an impressively researched column for Pharmaceutical Online, the frequency of Forms 483 issued to pharmaceutical companies has continued its steady rise over the past few years.

Note that for this and the following sections covering inspection observation trends, the data presented adheres to the analysis methodology and limitations described in the introduction of the

Again, given the caveat of the limited public data available (the FDA’s data includes only Forms 483 issued through its electronic system and omits API manufacturers), some notable findings emerge regarding specific §211 citations.

As we explored in another article, 2019 saw the FDA put a greater compliance focus on over-the-counter (OTC) drugs and other health product manufacturers. In a July 2019 column for Pharmaceutical Online, we analyzed these OTC-specific compliance trends, pulling out the following common issues appearing in warning letters.

Nonconformance Management —Another recent trend afflicting OTC drugmakers mirrors a broader and well-documented trend throughout the drug and device space: inadequate nonconformance management. As demonstrated by a large number of citations issued specifically for “inadequate, incomplete, and undocumented investigations,” these warning letters offer evidence of a long-standing perception that an outsized focus is placed on immediate nonconformance correction rather than on thoroughly investigating and executing corrective and preventive actions following a comprehensive root cause analysis.

Roles, Responsibilities, and Authority of the Quality Unit —The internal quality unit (QU) has been the target of many recent warning letters to OTC drug and health product manufacturers as an underlying cause of product quality and GMP compliance problems. Numerous firms have been cited for having an inadequate QU. In the most egregious examples, firms lacked this designated team entirely. More often, however, regulators have cited firms for a lack of written procedures that govern the responsibilities and functions of this group. 21 CFR Part 211 is clear about the need to establish a “quality control unit” with the documented responsibility and authority to make critical decisions.

Based on a growing number of relevant warning letters, as well as analyses of enforcement trend data and public statements made by the FDA, it’s clear that a renewed focus has been placed on evaluating manufacturers of OTC drug and health products in key areas of GMP.

These areas of enforcement focus include ineffective quality units, poor testing of incoming materials and components (i.e., relying on a supplier’s certificate of analysis), poor product testing, poor analytical and microbial testing and validation methodology (including method suitability), and inadequate nonconformance management.

Here are the major takeaways for inspections and compliance, specifically back from FDA"s Report on the State of Pharmaceutical Quality: Fiscal Year 2019 :

Based on its 10-point inspection score, the overall average for inspections in FY2019 was 7.4.(US- and EU-based sites scored averages that were slightly higher: 7.7 and 7.6, respectively.)

Based on its 10-point inspection score, homeopathic products and sterile over-the-counter (OTC) products had the lowest average scores at 6.5 and 6.2, respectively. For more on recent chronic quality and compliance issues among OTC and health product manufacturers,

In its report, regulators went on to say, "These sections represent some of the key elements of an effective Pharmaceutical Quality System. These are potential areas of focus for manufacturing facility management to improve overall pharmaceutical quality and inspectional outcomes."

Publicly available warning letters and inspection observation data provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities within the quality system and beyond.

In many of its warning letters, the FDA has “strongly recommended” engaging a third-party consultant qualified in the relevant regulations to assist in meeting CGMP requirements.

While we help many companies resolve Forms 483 and warning letters, we also help prevent them from being issued in the first place. At The FDA Group, we plan and conduct effective internal quality audits to ensure your quality system is completely aligned with all documentation and operations — the critical part of any internal audit.

It has come to our attention that there is some false information regarding the price of iHealth Covid-19 Antigen Rapid Test (the "Kit") in the U.S. market.

We, iHealth Labs Inc, hereby clarify that we and our authorized distributors are the only organizations in the U.S. that may legally sell and distribute the Kit under FDA EUA. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc.

Despite evidence to the contrary, the FDA has long defended its efforts to prevent opioids from entering the country by intercepting prescription drug packages delivered through international mail, according to a report from Kaiser Health News (KHN).

In fact, the agency"s own data revealed that confiscated packages did not contain significant amounts of opioids. The FDA said that just 33 packages of opioids and no fentanyl were found in the 53,000 drug shipments its investigators examined in 2022, which amounts to roughly 0.06% of the total packages searched, KHN reported.

Because the FDA has claimed that confiscating these international packages was preventing the import of opioids, pharmaceutical companies have used this claim to lobby against proposals in Washington, D.C. to allow Americans to buy their prescription drugs from countries where those drugs are cheaper, such as Canada.

The report noted that of the drugs confiscated by the FDA in 2020, the number one most common item was sildenafil, a generic form of the erectile dysfunction drug Viagra. Other common medications seized included those for asthma, diabetes, cancer, and HIV.

According to KHN, the FDA has been given millions of dollars to fight the shipment of opioids into the U.S., despite the limited evidence that these drugs are entering the country this way.

Nicole Sirotek, the founder of the group, gained notoriety for spreading COVID vaccine misinformation. While she no longer works as a nurse, she has raised tens of thousands of dollars through her social media presence.

Tyler Kuhk, ARNP, MN, who practices in Washington state, told VICE Newsthat he has been subjected to relentless harassment from the group, including being called a pedophile and being reported to police for allegedly threatening kids. His workplace has also been targeted with a barrage of messages demanding that Kuhk be fired.

"I stand by my dedication to the profession and the care I have for these issues, but the risks almost seem to outweigh the benefits at this point, financially, professionally, and mentally," Kuhk said.

She was readmitted to the hospital and scheduled for "a new experimental surgery" to implant two $15,000 devices that would address "a tear in the lining of her aorta," the Times reported. Higgins was told that the procedure would only take 90 minutes, according to her testimony in a lawsuit brought by a fellow doctor at Harbor-UCLA Medical Center, Timothy Ryan, MD, who was the first surgeon to treat Higgins.

According to the Times, White and another Harbor surgeon were being paid by Medtronic, the maker of the devices implanted in Higgins. As part of the lawsuit brought by Ryan, the doctors testified that they had received payments for Higgins" surgery because they were also teaching a course about the device.

However, Ryan alleged that no doctors were trained during the surgery and that the procedure was not medically necessary in the first place. The Times also reported that White later changed his testimony to say that he was paid by Medtronic for a different surgery earlier in the day.

Millions of parents rely on our formula to feed their babies. And we know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage. We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies.

Abbott is working closely with the U.S. Food and Drug Administration (FDA) to restart operations at the Sturgis, Mich., facility. We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall. In the meantime, we are working to increase the supply of infant formula by prioritizing infant formula production at our facilities that provide product to the U.S. market.

We have an FDA-registered plant in Cootehill, Ireland, where we"ve increased the volume of Similac Advance powder formula produced for the U.S. We"re air-shipping product from this facility into the U.S. daily and the product is being restocked regularly.

Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. Following stringent quality and safety processes, each batch of infant formula undergoes extensive quality checks before it reaches stores.

Columbus, Ohio, is the headquarters for Abbott"s U.S. nutrition business and is home to one of our five manufacturing facilities that produce infant formula for the U.S. market. At this facility we"ve made significant changes to ensure we can prioritize production of Similac Ready-to-Feed liquid formula, a product that can be used directly from the bottle. In the second quarter of the year, we expect to produce nearly three times more Similac Ready-to-Feed liquid formula than we did during the same period of time last year. And this product will be available on retail shelves and online soon.

Across the U.S., we"re prioritizing production of infant formula products to help replenish the supply in the market. And, this year, we will more than double the amount of Similac Advance powder formula we"re bringing in from our manufacturing facility in Cootehill, Ireland.

We are dedicated to doing everything possible to ensure parents and caregivers have what they need to feed their babies. And we"re always focused on what we can do to continue to serve our customers. We will continue to work closely with the FDA to implement corrective actions at the Michigan facility.

We are currently reviewing the FDA"s observations as provided in its Form 483 from its inspection of our powder formula manufacturing in our Sturgis, Mich., facility. We"re taking this very seriously and are working closely with the FDA to implement corrective actions.

While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases. This follows the FDA"s removal of the Salmonella case from its investigation earlier this month.

Abbott is committed to upholding the highest standards for manufacturing of all nutrition products. We have already begun implementing corrective actions and enhancements at the facility, leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there. Our actions include:

Consulting with industry experts to implement the latest technological advancements in food manufacturing processes, including a 3D augmented reality system, which will provide a clearer visualization of product as it moves through the facility, enhancing Abbott’s ability to make informed decisions (including remotely) during the manufacturing process

We know there are constraints in infant formula supply and we’re taking action to help address this. We have a global manufacturing and supply network we’re leveraging to better meet demand and increased production at an FDA-registered facility in Europe and are air freighting in Similac Advance infant formula powder. Our other U.S. plants continue to supply infant formula to the market and we’re prioritizing some production from other liquid nutritional products to Similac. Actions we’re taking to address supply include:

Working with USDA and state agencies to provide authorization for parents who get formula from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) with other Similac products at no cost, including for other manufacturers" products

We know that millions of parents and caregivers around the world count on our formulas to feed their babies and children and we are doing everything possible to address this situation.

Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 1999: Hearings Before a Subcommittee of the Committee on Appropriations, United States Senate, One Hundred Fifth Congress, Second Session, on H.R. 4101/S. 2159, an Act Making Appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Programs for the Fiscal Year Ending September 30, 1999 ... Commodity Futures Trading Commission, Department of Agriculture, Food and Drug Administration, Nondepartmental Witnesses

States, or which shall copy or simulate a trade-mark registered in accordance with the provisions of this act. or shall bear a name or mark calculated to induce the public to believe that the article is manufactured in the United States, or that it is manufactured in any foreign country or locality other than the country or locality in which it is in fact manufactured...‎

Country" means the political entity known as a nation. Colonies, possessions, or protectorates outside the boundaries of the mother country are considered separate countries. (b) Country of origin. "Country of origin" means the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin...‎

Such article is to be processed in the United States by the importer or for his account otherwise than for the purpose of concealing the origin of such...‎

Expenses included. In formulating charges for expenses pertaining to supervision of exportation, destruction, or marking, there shall be included all expenses of transportation, per diem allowance in lieu of subsistence, and all other expenses incurred by reason of such supervision from the time the Customs officer leaves his official station until he returns thereto. (d) Services rendered for more than one importer. If the importations of more than one importer are concurrently supervised, the service...‎

... be glazed on in the process of firing; and on paper articles be imprinted. (b) Degree of permanence and visibility. The degree of permanence should be at least sufficient to insure that in any reasonably foreseeable circumstance, the marking shall remain on the article (or its container) until it reaches the ultimate purchaser unless it is deliberately removed. The marking must survive normal distribution and store handling.‎

CFR part 134 provide that the articles or their containers must be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article or container will permit, in such a manner as to indicate to an ultimate purchaser in the United States, the English name of the country of origin of the article. (e) Duties and Penalties. Failure to comply with the certification requirements in paragraph (a) may subject the importer to a demand for liquidated damages under § 134.54(a)...‎

The products of the territory of any contracting party imported into the territory of any other contracting party shall be accorded treatment no less favourable than that accorded to like products of national origin in respect of all laws, regulations and requirements affecting their internal sale, offering for sale, purchase, transportation, distribution or use.‎Less

In this volume, Michael Jensen and his collaborators present the foundations of an integrated theory of organizations. The theory assumes that organizations are equilibrium systems that, like markets, can be influenced, but cannot be told what to do; that human beings are rational and self-interested for the most part; and that information is costly to produce and transfer among agents. The theory also treats business organizations as entities existing in a system of markets (including financial, product, labor, and materials markets) that must be considered in the formulation of organizational strategy.

Jensen argues that the cost of transferring information makes it necessary to decentralize some decision rights in organizations and in the economy. This decentralization in turn requires organizations to solve the control problem that results when self-interested persons do not behave as perfect agents.

Capitalist economies solve these control problems through the institution of alienable decision rights. But because organizations must suppress the alienability of decision rights, they must devise substitute mechanisms that perform its functions. Jensen argues that three critical systems, which he calls the organizational rules of the game, are necessary to substitute for alienability in organizations: (1) a system for allocating decision rights among agents in the firm, (2) a system for measuring and evaluating performance in the firm, and (3) a system for rewarding and punishing individuals for their performance. These concepts offer a major competitive advantage for organizations.

Dr. Goldman is a reproductive epidemiologist and Director of Clinical Research in the Department of Obstetrics and Gynecology and of Community and Family Medicine at Dartmouth-Hitchcock Medical Center. She specializes in research and teaching related to women"s health. Her research program includes several large randomized clinical trials evaluating optimal infertility treatment for younger and older women seeking to conceive and a prospective cohort study investigating the role of preconception nutrition and oxidative stress on implantation and early pregnancy loss. She is co-editor of Women and Health, a comprehensive reference textbook for researchers, teaching faculty, and clinicians on the role of gender in understanding disease occurrence, diagnosis, treatment, and priority-setting in health care.

Portable & Easy-to-Use: The Large LED digital screen makes the readings clear and easy to follow, while the convenient size and carrying pouch make it extremely portable. The universal cuff works for almost anyone with arm circumferences ranging from 9-to 17 inches.

Intended for adult indoor use only. The device should not be used by any person who may be suspected of, or is pregnant. The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, and defibrillators. Consult your physician if your measuring falls outside the AHA range. Only your doctor can determine and confirm whether blood pressure has reached a dangerous point.

Measurement Readings: This product uses an Oscillometric Measuring method. Before each measurement, the device establishes a "zero pressure" equivalent to atmospheric pressure. While the arm cuff inflates, the device detects pressure oscillations generated by, beat-by-beat pulsation. This process detects the systolic and diastolic pressure as well as the pulse rate.

Symbol: SYS Description: Systolic blood pressure Symbol: DIA Description: Diastolic blood pressure Symbol: PUL description: Pulse in beats per minute 100mmx68mm Digital LCD Display