FDA 483 - Medical Products Laboratories, Inc. - October 16, 2025

Medical Products Laboratories, Inc. in Philadelphia was cited for significant Good Manufacturing Practice (GMP) violations during an FDA inspection. The firm failed to establish adequate production and process controls, including unvalidated manufacturing processes and formulation changes, and exhibited a lack of thorough investigations into product complaints and microbial contamination. Additionally, the quality control unit demonstrated a lack of authority by improperly handling stability failures and releasing products without sufficient scientific justification.