FDA 483 - diplomat pharmacy inc. - November 17, 2017

During an inspection from October 31 to November 17, 2017, the FDA issued a Form 483 to Diplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy, a producer of sterile and non-sterile drug products in Flint, Michigan. The observations highlighted several significant deviations from regulatory standards, primarily concerning good manufacturing practices and sterile product control. Key issues included critical cleanliness failures within the ISO 5 classified aseptic processing areas, where inspectors observed rust-colored residues and discolorations on laminar flow hoods and HEPA filter screens, indicating inadequate cleaning and potential contamination risks. Furthermore, a HEPA filter patch exceeding specified size limits compromised the sterile air quality in a processing hood, where sterile drug products like Enoxaparin and Neupogen were routinely prepared. The company also used non-sterile cleaning wipes in these critical sterile processing environments, even when used with sterile disinfectants, which directly jeopardized product sterility. A serious quality control violation involved the release of Dexamethasone 40 MG and 10 MG capsules that initially showed out-of-specification potency results (153% and 143% respectively). Although subsequent re-tests were within limits, affected lots were dispensed to patients prior to the receipt of these OOS results, demonstrating a failure in product release protocols. These observations indicate a need for immediate corrective actions to ensure compliance with Current Good Manufacturing Practices, particularly in maintaining aseptic conditions and robust quality control for drug product release, to protect patient safety.