FDA CGMP Warning Letters in 2006

Rockville, MD (Dec. 28)-Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration (www.fda.gov) in 2006.

These included 17 CGMP warnings for drug products (including medical gases), four for active pharmaceutical ingredients, one for a biological, and 14 warnings to compounding pharmacies (reflecting the agency's continuing conflict with compounders) (see Table I).

Medical device operations, by comparison, received 73 official CGMP warnings during the year, and blood and blood-product producers were warned 8 times for CGMP shortcomings. (FDA issued the great majority of 2006's Warning Letters for false and misleading advertising, with about 100 citations, and a variety of food-processing problems, ranging from illegal drug residues in milk to errors in processing seafood.)

Nineteen FDA district offices issued 30 of the 36 pharmaceutical CGMP warnings (and 104 of the 117 overall medical CGMP letter). The New Jersey District Office issued four pharmaceutical CGMP warnings, more than any other office (though the Center for Drug Evaluation and Research in Rockville also issued four Warnings). The Cincinnati and Florida District Offices issued three citations each-all to compounding pharmacies.

See Table II for a chronological listing of pharmaceutical and device CGMP warning letters issued over the past year.

Table I: Number of US Food and Drug Administration 2006 Current Good Manufacturing Practices (CGMPs) Warning Letters

Table II. US Food and Drug Administration 2006 Current Good Manufacturing Practices (CGMPs) Warning Letters

pharmacy
compounding