New - FDAzilla's FDA Inspections Database

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Inspection and 483 data sliced and diced in a very interesting way. Check it out! 

Start with the first link below to get oriented, then dive right in to the data via the second link below.

FDA Inspections Database is Now Available | FDAzilla Blog:

"We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details."

Follow this link to The FDAzilla FDA Inspection Dashboard and Database

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FDA - 70% of Supplement Companies Violate Rules

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FDA official: 70% of supplement companies violate agency rules:

"About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations over the past five years, according to a top agency official.

Consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications -- even bacteria in pediatric vitamins, recall notices and agency inspection records have shown."

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FDA Cites 70% of Dietary Supplement Firms on GMPs

FDA GMP Inspectors Cite 70% of Dietary Supplement Firms:

"During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.

A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request."

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FDA Seizes Illegal Dietary Supplements in FL

FDA Seizes Illegal Dietary Supplements in FL | Designated Representative and Exemptee:

"WASHINGTON: FDA seizes illegal dietary supplements in Florida - Business Breaking News - MiamiHerald.com:

"Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.

Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards."

For additional details:
FDA Warning Letters - Globe All Wellness, LLC 2/6/12

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Related articles

• Titan Medical Enterprises Shut Down for GMP Violations (drughealth.blogspot.com)

Titan Medical Enterprises Shut Down for GMP Violations

Press Announcements > Court shuts down U.S. operations of California drug, dietary supplement manufacturer:

"The court found that the company and McDaniel violated the Act by failing to follow current Good Manufacturing Practice for drugs (Drug cGMP) and for dietary supplements (Dietary Supplement cGMP). The court also found that the defendants violated federal law by distributing unapproved new drugs in violation of the Act. Prior to entry of the court’s order, Titan Medical Enterprises manufactured and domestically distributed a variety of drugs and dietary supplements."   . . .

Drug cGMP includes practices and systems required to be adopted in the manufacture and testing of pharmaceuticals. Drug cGMP outlines the aspects of production and testing that can impact the quality of a product.

Similarly, Dietary Supplement cGMP regulations require dietary supplement manufacturers to ensure quality in their dietary supplements by appropriately controlling all aspects of their processes and procedures to ensure a supplement meets minimal quality standards and is not adulterated by the presence of contaminants.

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Ben Venue Signs FDA Consent Decree Over Drug Manufacturing Problems

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Updated October 19, 2020

The link in the original post broke.

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Ben Venue Signs Consent Decree With FDA To Address Manufacturing Problems at Plant - Bloomberg Law

- - -  original post follows below  - - -

Ben Venue Signs Consent Decree with FDA Over Drug Manufacturing Problems | Fox Business:

"Ben Venue Laboratories, the contract drug manufacturer whose quality lapses caused a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil and recalls of numerous other drugs, reached an agreement with U.S. authorities governing the company's efforts to fix the problems.

Ben Venue, a Bedford, Ohio, division of Germany's Boehringer Ingelheim, signed a so-called "consent decree" with the Food and Drug Administration, according to a company statement and court documents filed by the Department of Justice in federal court in Ohio.

The consent decree bars Ben Venue from making and selling certain drugs until the company can demonstrate that it has taken certain steps to correct its manufacturing problems, among other requirements."

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FDA - Pharma Warning Letters and Notice of Violation Letters

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Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

"These letters are supplied by the CDER Freedom of  Information Office (FOI).  This page only covers letters issued by Headquarters and the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications).  For District Office warning letters, please see the Main FDA FOI Warning Letters Page.

Some of the letters have been redacted or edited to remove confidential information.  Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. "

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FDA Warning Letters - Common Violations

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Updated April 25, 2024

The original link broke.

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Trends In FDA FY2023 Inspection-Based Warning Letters - Outsourced Pharma

---  the original post follows below  ---

The author reports six categories of the most common violations . . .

FDA warning letters: the most common violations highlighted | Life Sciences Articles:

"Before the FDA takes enforcement action on negative inspection findings, it issues a warning letter. From an analysis of 87 such letters, we learned a lot about what the FDA is looking for and ways to keep you from receiving a letter yourself. Here is the countdown of the most common violations mentioned in FDA Warning letters."

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Will the FDA issue 10,000+ 483s in 2011?

FDA will issue 10,000+ 483s in 2011 – one every 52 minutes FDAzilla Blog:   'via Blog this'

The number is kind of shocking!  According to the FDAzilla Blog:

"Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year."

According to e-How - The Definition of FDA 483:

FDA Form 483, is the form on which inspectors for the Food and Drug Administration detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices (cGMP). The FDA inspects plants making human drugs (both prescription and over-the-counter drugs), animal and veterinary drugs, medical devices, food, radiation-emitting products, vaccines, blood and biological products and cosmetics for compliance with cGMP.

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Inspection Detection - a GMP training game by SkillsPlus Intl Inc.

An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.

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FDA Compliance Manual For Dietary Supplements

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Updated May 7, 2021

The original link broke.

You can still read more about this topic at:

FOOD AND DRUG ADMINISTRATION - COMPLIANCE PROGRAM GUIDANCE MANUAL - CHAPTER 21 – FOOD COMPOSITION, STANDARDS, LABELING, AND ECONOMICS - DIETARY SUPPLEMENTS – FOREIGN AND DOMESTIC INSPECTIONS, SAMPLING, AND IMPORTS (IMPLEMENTATION DATE: 09/30/2020) - PDF | FDA.gov 

---  the original post follows below  ---

The FDA recently made the following available online, Dietary Supplements, Import and Domestic - Ch 21 Food Composition, Standards, Labeling, and Economics - Food and Drug Administration (FDA) - Compliance Program Guidance Manual.

It's a great reference that should be reviewed by everybody in the dietary supplement sector. Of note:

1. Part III - Inspectional - a wonderful listing of things to pay attention to, in almost checklist fashion
2. Part V-A - GMP Violations - watch out! Don't commit any of these major deviations:

• Lack of master manufacturing records or significant requirements not included
• Lack of finished product release criteria or failure to test (all or subset of finished batches) or meet finished product release criteria critical to product safety and quality
• For significant dietary ingredients, e.g. those that make up the bulk of the product, failure to establish specifications for incoming material or failure to conduct identity testing
• No quality control review procedures or significant quality control procedures not implemented
• No batch records
• Significant physical plant deficiencies.

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Avoid The DOJ - FCPA Violations - Foreign Corrupt Practices Act

I never heard about the FCPA (Foreign Corrupt Practices Act) until reading about it today. Wikipedia says FCPA addresses accounting transparency requirements under the Securities Exchange Act of 1934 and another concerning bribery of foreign officials.

Anyways, FDANews reports that the Department of Justice’s (DOJ) FCPA and healthcare fraud units are beginning to work together to investigate FCPA violations in the device and pharmaceutical industries. The DOJ has more information about FCPA on their website.

Here's why you need to care. The DOJ wants to aggressively enforce and investigate violations of the FCPA, targeting pharmaceutical and medical device companies as well as their individual executives and board members; this leaves them open to potentially massive legal and financial liabilities.

Additional Resources:
Bribery Abroad: Lessons from the Foreign Corrupt Practices Act

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FDA Offers Warning Letter Close-Out Letter Program

According to the FDA's announcement, Warning Letter Close-Out Letter Program, the FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009. 

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FDA Says Cheerios Makes False Claims

The FDA tells General Mills CEO, "The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov." Ooooh, what a spanking! ... as reported in this FDA Warning Letter to Ken Powell, Chairman of the Board and CEO. Read more about this on this Fox Austin article, "FDA: Cheerios Makes False Health Claims. 

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CAPA Problems - Most often cited 483 deficiency

You'll do well by reading this well-written article by Barbara Immel, "Converting CAPA to an Advantage - CAPA violations still generate a substantial number of warning letters. These tips can help make CAPA systems a benefit instead of a liability." Her writings are packed full of great content. Don't miss out on these pearls of wisdom and well referenced article.

In concluding, she writes, "CAPA deficiencies are one of the most common items cited in warning letters to medical device manufacturers. Therefore, it is critical for manufacturers to understand how to develop a CAPA system and how best to use it. . . ."

Related Posts:
Free FDA Compliance Library (Immel Resources LLC - Pharmaceutical, Medical Device, Biologics and Related Industries)
FDA Says - Unwise To Ignore Form 483
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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