FDA will issue 10,000+ 483s in 2011 – one every 52 minutes

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 10,407 483s, breaking the previous high-water mark of 9,666 in 2009.  Through June 30, 2011, the FDA has issued 5,547 483s, approximately 100 more 483s than the same time period in 2010, roughly a 2% increase.

This begs the question – is more 483s better?  Is the nation safer with more inspectors pounding the pavement?  Think about this – 10,000 483s per year – that’s one 483 every 52 minutes.

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.  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 483s List Search.

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

 

 

 

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