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

Alps Pharmaceutical Industrial Co. Ltd. in Hida, Gifu, Japan, received a Form 483 with three observations during an inspection from May 22-26, 2023. The observations primarily concern deficiencies in software validation for their ERP system, inadequate controls for personnel signatures on cGMP documents, and a failure to verify analytical methods for finished product testing after instrument changes. These issues indicate significant concerns regarding data integrity and quality control processes.