FDA 483 - Health Pharma USA LLC - November 18, 2025

An FDA inspection of Health Pharma USA LLC in Rahway, NJ, a drug and dietary supplement manufacturer, revealed numerous significant deficiencies. The firm failed to establish adequate written procedures for production, process controls, equipment maintenance, and quality control, and lacked proper validation for manufacturing processes and computer systems. Additionally, insanitary conditions were observed, and critical specifications for dietary supplement components and products were not established or followed.