FDA 483 - Alps Pharmaceutical Industrial Co., Ltd. - May 26, 2023

An FDA inspection of Alps Pharmaceutical Industrial Co. Ltd. in Hida, Gifu, Japan, an Active Pharmaceutical Ingredient (API) Manufacturer, revealed significant deficiencies. The firm failed to validate its cGMP-related software system, lacked controls for authentic personnel signatures on cGMP documents, and did not verify analytical methods for finished product testing after instrument changes.