BREAKING NEWS – FDA Breaks All-Time Record, Issuing 10,000 483s
November 4, 2011 / /
There are reports that the FDA will surpass 10,000 483s (the citation given before a formal warning letter) in 2011 for the second time in its history, breaking its all-time record for the third consecutive year. That averages out to a new 483 every 52 minutes!
Marc C. Sanchez – Contract In-House Counsel and Consultant(sanchezmarc.com)
Focused on helping manufacturers, distributors, and importers quickly resolve FDA audits and respond to 483s and Warning Letters.
Posted in FDA Enforcement, FDA News Update and tagged with 483 RESPONSE, 483S, FDA, FORM 483, NOTICE OF INSPECTIONAL OBSERVATIONS, WARNING LETTER, WARNING LETTER RESPONSE
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