FDA 483 - Meiji Seika Pharma Co., Ltd. - Gifu Plant - September 02, 2022

During an FDA inspection conducted from August 29 to September 2, 2022, Meiji Seika Pharma Co., Ltd.'s Gifu Plant, an Active Pharmaceutical Ingredient (API) manufacturer, received a Form FDA 483 outlining significant observations related to their quality system, facilities, and equipment. A primary concern identified was the absence of an independent quality unit. Specifically, the Validation Manager was observed approving validation protocols, reports, and releasing equipment for production, responsibilities typically falling under an independent Quality Assurance unit, indicating a potential conflict of interest and lack of proper oversight. Furthermore, the inspection revealed inadequate controls over computerized systems. A computer used for printing finished product and shipping labels lacked unique user login credentials, posing a risk of unauthorized label generation. The label room's key control log also failed to accurately record access during label printing operations. Finally, the facility exhibited poor maintenance, with water leak damage and mold growth observed on ceiling tiles in Raw Material Warehouse No. 1, compromising the integrity of storage conditions for intermediates and active pharmaceutical ingredients. Meiji Seika Pharma Co., Ltd. is required to promptly address these observations by implementing comprehensive corrective actions to ensure compliance with good manufacturing practices and prevent recurrence, safeguarding product quality and patient safety.