by Tony Chen

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.  In 2010, the FDA issued 10,437 483s, breaking the previous high-water mark of 9,666 in 2009.  Through November 2, 2011, the FDA has issued 9,052 483s, approximately 215 more 483s than the same time period in 2010, roughly a 2.4% increase.  Extrapolating for the rest of the year, we expect the FDA to issue roughly 10,690 483s for 2011.  That’s one 483 every 50 minutes.  We have updated our searchable list of FDA 483s to include this new data – this is the only place on the web you can access this data.

As we’ve mentioned before, this has been a notorious year for this obscure, technical document known as the FDA Form 483.  In February, MSNBC reporter JoNel Aleccia broke a front-page story on the now-infamous “tainted alcohol wipes” made by the Triad Group that has led to 2 recalls, 2 lawsuits, an FDA investigation, and certainly more still to come.   The follow-up article actually quotes the inspection observations noted by the FDA inspector on the FDA Form 483.  Triad plans to “move away” from it’s healthcare division.

Genentech recently stated in a statement to a prominent industry newsletter their approach in responding to 483 observations – timely, thorough, and complete.

Just this week, a prominent Forbes article weighed in on the possibility of Hospira getting a consent decree for its manufacturing problems – the article even links to the actual 483 documents.  Hospira is reported to commit $375 million to getting their manufacturing facilities up to FDA compliance par.

Also this week, Mylan received a warning letter, in part, for not adequately addressing observations cited in a previous 483.

For more on 483s, go to our Top 10 List of Resources to understand and avoid 483s.  For the most recent listing of 483s, go to our FDA 483s List Search – new data includes all 483s up to November 2, 2011.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.