FDA 483 - Sato Pharmaceutical Co., Ltd. - November 21, 2025

Sato Pharmaceutical Co., Ltd. in Hachioji, Tokyo, Japan, an OTC drug manufacturer, received a Form 483 with ten observations highlighting significant deficiencies in aseptic processing, quality control, and stability testing. The firm failed to adequately investigate media fill failures and contamination, lacked proper validation for aseptic processes, and had inadequate stability testing programs and laboratory controls, including releasing products without required microbiological testing. Additionally, issues with equipment maintenance and protective apparel were noted, indicating a broad range of quality system breakdowns.