Health Pharma USA LLC – FDA Warning Letter, Jun 3, 2019

The FDA inspected Health Pharma USA LLC's drug manufacturing facility in Rahway, New Jersey, from May 13 to June 3, 2019, identifying significant current Good Manufacturing Practice (CGMP) violations. Consequently, the firm's drug products are deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include an inadequate quality control unit (21 CFR 211.22), which failed to ensure CGMP compliance, lacked essential procedures, shipped drug products before final review, and maintained an insufficient stability program. The firm also failed to prepare complete batch production and control records (21 CFR 211.188), with missing critical information for manufacturing processes and packaging. Furthermore, adequate written procedures for production and process control were not established or approved by the quality unit (21 CFR 211.100(a)), leading to inadequate process validation. Finally, the firm failed to test incoming components for identity, strength, quality, and purity, and did not validate supplier certificates of analysis (21 CFR 211.84(d)(1) and (2)). The FDA noted the firm's quality systems are inadequate and strongly recommended engaging a CGMP consultant. Health Pharma USA LLC must respond within 15 working days with comprehensive corrective and preventive action plans. Failure to promptly correct these violations may result in legal action, including seizure and injunction, and could impact export certificates and drug application approvals.