FDA 483 - ABS Corporation - August 11, 2023

ABS Corporation, a contract manufacturer in Omaha, NE, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately investigate out-of-specification results, lacked proper validation for production and cleaning processes, and exhibited poor data integrity controls over its laboratory computer systems. Additionally, the quality control unit's responsibilities were not fully documented, including the absence of critical quality agreements with customers.