FDA 483 - Folsom Metal Products, Inc. - August 01, 2025

Folsom Metal Products, Inc. in Pelham, AL, a manufacturer of medical devices, was cited for significant and repeat deficiencies across its quality management system. The inspection revealed inadequate validation of critical manufacturing processes, ineffective corrective and preventive actions, and failures in controlling nonconforming products. Furthermore, the firm demonstrated a lack of adequate management controls, including insufficient personnel qualifications and resource allocation, severely impacting its ability to maintain system effectiveness.