Amphastar Pharmaceuticals, Inc. – FDA 483, Mar 1, 2024

An FDA inspection of Amphastar Pharmaceuticals, Inc. in Rancho Cucamonga, CA, a sterile drug and combination drug/device manufacturer, revealed significant deficiencies across its laboratory, quality, and medical device systems. Observations included inadequate computer system controls, unvalidated Excel spreadsheets, incomplete laboratory records, and a lack of timely complaint investigation closures. The firm also failed to adequately establish test method accuracy, expand investigations into document control errors, and conduct timely design reviews for a medical device.