FDA 483 - Tsukioka Film Pharma Co., Ltd. - May 24, 2019

An FDA inspection of Tsukioka Film Pharma Co., Ltd. in Kakamigahara, Gifu, Japan, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate out-of-specification (OOS) investigations, unvalidated test methods for impurities, and poorly maintained equipment. These issues indicate a failure to ensure the quality, purity, and safety of drug products distributed to the United States.