German Company Warned for Incomplete GMP Procedures

The FDA cited German devicemaker Stratec Medizintechnik for failing to adequately document the acceptance or rejection results for functional testing of its printed circuit boards, according to a warning letter. Stratec, which manufactures bone densitometers, responded to good manufacturing practice (GMP) citations it received after an inspection of its Pforzheim, Germany, plant. Because the response was not translated into English, the FDA considered it unclear and incomplete.
The GMP Letter