FDA’s aggressive enforcement against pharmaceutical manufacturers for GMP violations continued in the first half of the year through its use of warning letters. Inadequate contamination controls was a common deficiency found in eight of the 18 drug GMP warning letters, failure to investigate out-of-specification results continues to be the most frequent GMP deficiency in warning letters, and cites of stability problems are increasing.
FDA’s aggressive enforcement against pharmaceutical manufacturers for GMP violations has continued, with the agency issuing 18 warning letters in the first half of 2012, just as it had in the last half of 2011.
Inadequate control of contamination was a common problem found in drug GMP warning letters going to manufacturers of finished drugs and active pharmaceutical ingredients