FDA 483 - Amphastar Pharmaceuticals, Inc. - March 01, 2024

Amphastar Pharmaceuticals, Inc. received an FDA Form 483 following an inspection from February 20 to March 1, 2024, at its sterile drug and combination drug/device manufacturing facility. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, identified significant compliance issues across laboratory, quality, and medical device control systems.

Key observations included deficiencies in the laboratory system, such as unsecure computer data backups allowing file deletion, unvalidated Excel spreadsheets for critical calculations, and inadequate controls where personnel with data deletion access also reviewed audit trails. Additionally, test methods lacked established accuracy, and laboratory records were incomplete, relying on uncontrolled worksheets.

Within the quality system, the FDA noted that approximately 150 complaint investigations from 2023 remained open for extended periods without documented justification or oversight. The firm also exhibited inadequate validation documentation for bacterial endotoxins testing, procedural discrepancies, and a lack of quality unit review for critical documents. Investigations into document control errors in master production records were not adequately expanded to assess their impact on other batches. Furthermore, for medical devices, design reviews for Enoxaparin for Injection, USP had not been conducted since 2016, violating internal procedures. Amphastar Pharmaceuticals is now required to implement comprehensive corrective and preventive actions to address these observations and ensure regulatory compliance.