FDA has posted a Form 483 issued in March 2014 to Wockhardt’s Morton Grove Pharmaceuticals facility. Detailed in the FDA-483 are a variety of quality control, GMP, and sanitation issues observed during an investigation conducted from January to March 2014. Observations included using chromatography testing and stability monitoring procedures for which the company previously received FDA warning letters at two other plants. Specifically, the company has been using “trial” injections during chromatography testing without proper documentation procedures.
The FDA-483 also noted the company had not properly followed stability testing programs and had failed to properly review batch discrepancies and document out-of-specification investigations. To further the quality problems noted, the FDA investigator stated that the quality control unit did not fully investigate errors, and operating procedures were not properly updated when changes occurred.
The company was also cited for failure to maintain clean and sanitary conditions, including observations of mold and improperly sanitized equipment. The FDA inspector also cited improper personnel gowning and health habits.