FDA Warning letter trending FY2012

The following is a FY2012 YTD report of warning letters issued by FDA. CDRH continues to be the  clear lead as the office with most letters issued at 85 letters. This is roughly equivalent to FY2011's number at the same period. Total warning letters cited numbered at 610. cGMP/QSR/Medical Device is the second most often cited violation.

Definition of medical device is generally applicable to a wide number of products. Manufacturers and component suppliers may not be sufficiently aware of QSR requirements, or in many cases, may not  have sufficient resources to be fully compliant with QSR requirements. 

Subjects of Warning letter by count: CGMP/QSR/Medical Devices/Adulterated 58 Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 44 Illegal Drug Residue 40 Seafood HACCP/CGMP for Foods/Adulterated 28 CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 23 CGMP for Finished Pharmaceuticals/Adulterated 21 CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 20 Seafood HACCP/Adulterated 20 New Drug/Misbranded 19 Animals for Sale for Slaughter as Food/Adulterated 17 Modified Risk Tobacco Products 15 Medical Device Reporting/Misbranded 14 CGMP/QSR/Medical Devices/Adulterated/Misbranded 14 Clinical Investigator 14 Premarket Approval/Misbranded/Adulterated 13 CGMP for Foods/Seafood HACCP/Adulterated 11 CGMP Regulation For Food/Adulterated 10