FDA 483 - APL HEALTHCARE LIMITED - December 17, 2025

APL HEALTHCARE LIMITED in Menakuru, India, was cited for significant deficiencies across its quality system. Observations included inadequate complaint investigations for leaking products and particulate contamination, failure to follow quality control procedures, and deficient quality risk management for high-potency drugs. Additionally, the firm failed to establish accurate test methods, maintain clean equipment, and ensure proper cleaning validation before subsequent batch production.