GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Updated August 4, 2024

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Warning Letters - FDA.gov

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Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 

that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

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Dietary Supplement Warning Letter Immersion Center - Letters Categorized by Type

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Updated July 22, 2021

The original link broke.

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Warning Letters Related to Food, Beverages, and Dietary Supplements - FDA.gov

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If you're tracking FDA Warning Letters issued to dietary supplement companies, follow the link below:

NPI Warning Letter Immersion Center:

"This Warning Letter Immersion Center is a place to find the latest information on warning letters sent to dietary supplement and related companies. Included is a table of all the known warning letters to date, including a link to the full text of each letter on FDA website."

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FDA - Unusual Letter Sent To iPhone-Based Testing Device Co

FDA Sends Unusual Letter to Maker of iPhone-Based Testing Product:

"(FDA) revealed that it had sent off another type of letter to a medical device company, one rarely publicized by the agency."  . . .

"Prior FDA explanations make clear that the letters are part of a "triage" strategy practiced by the agency's device regulators in which the "It Has Come To Our Attention" letter follows a "call to clarify," preceding further actions such as an Untitled Letter, Inspection or Warning Letter."

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FDA Asked About Mobile Apps and the FDA 510K Process

Congress asks FDA if “actual use” is factor in medical app regulation | mobihealthnews:

". . . The letter also asks whether the FDA will consider the “actual use” of a mobile medical app in addition to the “intended use” when making its determination about whether an app needs to go through the 510(K) process. Finally, the letter closes with a series of questions related to the final guidance document and the committee wants answers by March 15th."

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Read the Letter Sent to FDA Commissioner Margaret Hamburg (pdf)

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• FDA Free Tips - Don't Fall for Health Fraud Scams (video) (drughealth.blogspot.com)

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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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

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

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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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FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,

"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."

Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:

• a plan
• what kind of data will be collected to measure the effectiveness of the plan
• a timeline for the plan
• the identification of resources allocated to address the issue

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Top 10 - Reasons Why CAPA or Deviation Investigation Systems Fail

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I ran across this post on The QA Pharm Blog,  The Top Ten Reasons the Deviation Investigation System Fails. It's a good read amongst some other pretty thought-provoking posts.

In a nutshell:

"Warning Letters are fraught with observations that point to issues with the deviation investigation system and the ability to solve problems once and for all. Here are my top ten reasons that the deviation/investigation/CAPA system fails: . . . "

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Root Cause Analysis for Better Investigations by SkillsPlus Intl Inc.

#FDA #GMP #cGMP #training #course #class

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Learn From 2010 FDA Warnings To Pharma Companies

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2010 is now behind us.  It's time to turn your attention to 2011. If you're in the FDA GMP training space, consider leveraging the following resource in your GMP trainings:  FDA Inspections, Compliance, Enforcement, and Criminal Investigations - Warning Letters.

From this main Warning Letters page, you can research and learn from the warning letters, that can be found by:

• Year
• Company
• Subject
• . . . and many other advanced search criteria

The Warning Letters can be used as great examples of just how important it is to comply with the regulations.

You might also be interested in:
Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

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FDA Issues Dietary Supplement Warning Letter

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Updated August 15, 2016

You might also be interested in this FDA guidance document:
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry - Draft Guidance (PDF)

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Here we go folks. It appears we're going to start seeing action by the FDA in the Dietary Supplements sector.

This FDA Law Blog post reports the issuance of an FDA warning letter, FDA Posts its First Dietary Supplement GMP Warning Letter.  A nice read.

If you want to see what else is going on, go to the FDA's Electronic Reading Room - Warning Letters - Browse Warning Letters By Subject - the letter D - scroll down to the Dietary Supplement selections.

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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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10 Tips - How to Avoid FDA 483 and Warning Letters

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Updated February 15, 2021

Links broke in the original post.

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Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments - MasterControl

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It never hurts to review or re-review your policies and procedures. 

Check out this white paper, Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations. 

Previous Posts: 

• CAPA Problems - Most often cited 483 deficiency 
• More FDA 483 Resources - Comments and Pearls from Validation Online 
• FDA 483 Inspectional Observations - learn from these examples 

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FDA Updates Warning Letters Web Page

The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site. The changes on the Web page are as follows:

• Every Tuesday, the most recently issued warning letters now will be presented under Recently Posted with the date posted.
• Effective Sept. 1, the Close Out Date is now provided in the Warning Letters table and detailed information about the Warning Letters Close Out Program is provided.
• Additional changes include formatting and improved page navigation to help users understand what searching and browsing options are available.

The “Warning Letters” page can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. The FDA will continue to look for ways to improve the “Warning Letters” webpage in the future.

Previous Posts: Food Industry Ramifications of the FDA Cheerios Warning Letter FDA Warning Letter - Space Shuttle Fruitcake

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Food Industry Ramifications of the FDA Cheerios Warning Letter

Sarah Sunday writes this excellent legal opinion explaining the background and ramifications of the FDA's warning letter to the makers of Cheerios, Is FDA Warning Letter An Ominous Signal To Food Industry? This is all about the FDA objecting to the statement that Cheerios can lower cholesterol levels. In a nutshell, she says:

"FDA's Warning Letter is a slap on the wrist in terms of the potential regulatory consequences. However, the letter could have a significant legitimizing effect on the pending California lawsuit, and in that way, could have costly implications for both General Mills and the food industry as a whole."

Previous Posts: And The Top 10 Food Stories Of 2008 Pet Food Sickened People - Did they eat it? . . . Time To Talk About Turkey Cooking and Food Safety FDA CFSAN - Food Safety and Nutrition Video Library (free) 

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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. . . ."

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FDA 483 Inspectional Observations - learn from these examples

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FDA Says - Unwise To Ignore Form 483

I've taken for granted that no one would intentionally want to ignore an FDA Form 483. But just in case you thought about it, you'll want to reconsider. Read this Outsourcing-Pharma post, "Ignore a form 483? Not wise say FDA." Bottomline, doing nothing increases the likelihood of receiving a warning letter. In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”. 

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FDA Warning Letter - Space Shuttle Fruitcake

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Updated March 6, 2019

WSJ put the article behind their subscription wall, and the link to the warning letter has broken.

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FDA: Pardon Me, But Your Bakery Warehouse Is Full Of "Rodent Excreta Pellets" - Consumerist

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This would be amusing if it wasn't so serious. I recommend you read this, and share it during an upcoming GMP training or classroom session. At first, I was slightly amused and drawn to this WSJ article by its headline, "Pay No Attention to the Mice Behind the Pallets." Then I read, and was appalled. Read on and take a gander at the FDA warning letter to Capitol Cake Co. BTW, they've proudly supplied fruitcake for the space shuttle program.

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