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Cindy Fazzi

Trends in Q1 FDA Warning Letters
by Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

Oct 30, 2012 | Free Downloads | email | Print

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Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.

For the purpose of this article, that's what I did. Specifically, I checked how many warning letters related to CGMP and CGTP violations were sent to pharmaceutical, blood/biologics, and medical device companies in the first quarter of 2012. I counted 35 such warning letters.

FDA violations can have serious ramifications, including seizure and injunction. Companies are given 15 days to respond to a warning letter, including a plan to correct violations.

With the help of a spreadsheet and lots of coffee, I reviewed the information available from the FDA website. I made a list of all 35 life science companies that received warning letters between January and March 2012 and identified their top five violations only. Some companies had only two or three violations; others had more than five.

I categorized violations by the regulation cited. In some instances, especially with pharmaceutical and blood/biologics companies, I combined related observations. For example, I combined 21 CFR 211.192 and 21 CFR 211.188 because the observations were all related to batch.

Out of the 35 warning letters, 23 were sent to medical device companies, nine to pharmaceutical, and three to blood/biologic companies.

The warning letters originated from the CDRH (11), CDER (eight), CBER (1), and also from FDA district offices in New Jersey (3), New York (1), Cincinnati (1), Philadelphia (2), New Orleans (2), Los Angeles (2), Atlanta (1), Kansas City (1), Minneapolis (1), and San Francisco (1).

Q1 2012: Top Violations

Here are the top violations I gleaned from my review:

Medical Device

Areas of NoncomplianceNo. of Companies Cited
21 CFR 820.100 (CAPA), 21 CFR 820.22 (quality audit)
21 CFR 820.198 (complaints)
21 CFR 820.30 (design controls)
21 CFR 820.75 (process validation)

Pharmaceutical/Blood & Biologics

Areas of NoncomplianceNo. of Companies Cited
21 CFR 211.113 (ctrl. of microbiological contamination)
21 CFR 211.100 (written procedures), 21 CFR 211.101 (components: written prod. & control procedures)
21 CFR 211.63 (equipment design), 21 CFR 211.67 (equipment cleaning and maintenance)
21 CFR 211.192 (production record review), 21 CFR 211.188 (batch production & control records)

FDA violations can have serious ramifications, including seizure and injunction. Companies are given 15 days to respond to a warning letter, including a plan to correct violations. Implementation of CAPAs can take days or weeks or longer, depending on the severity of the noncompliance and the corresponding resources that a company devotes to fixing the issues.

Hopefully this review of warning letters will encourage you to take a closer look at your own quality processes and think about how you can prepare for future FDA inspections. And, if you are so inclined, you can check out warning letters every now and then, and see what you can learn from them.


FDA warning letters were viewed on April 5, 2012, at:

Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master's degree in journalism from Ohio State University.

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