FDA 483 - Health Pharma USA LLC - July 03, 2024

Health Pharma USA LLC in Rahway, NJ, was inspected and found to have significant deficiencies across its quality control unit, equipment maintenance, laboratory controls, and stability programs. Repeated observations from a previous inspection indicate a persistent failure to establish and follow written procedures, maintain appropriate equipment, and ensure data integrity for OTC drug products. The firm's practices raise concerns about the identity, strength, purity, and quality of its manufactured drugs.