FDA WARNING_LETTER - Zydus Lifesciences Limited - April 23, 2024

The FDA issued a Warning Letter to Zydus Lifesciences Limited following an inspection from April 15-23, 2024, at their Vadodara, Gujarat, India facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate contamination. This includes multiple cross-contamination events from (b)(4) drug product in other batches due to inadequate cleaning, leading to a voluntary recall of Verapamil Hydrochloride Injection. Additionally, investigations into glass particulate contamination in Cyanocobalamin Injection USP were insufficient, lacking root cause identification and proper operator qualification for visual inspection, resulting in another voluntary recall. The FDA requires a comprehensive, independent assessment and remediation plan for their investigation system.

2. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** Poor aseptic techniques were observed, such as operators disrupting first-air in ISO-5 areas. Airflow simulations (smoke studies) for filling line (b)(4) were inadequate, failing to demonstrate unidirectional airflow during interventions. The FDA demands a comprehensive risk assessment of contamination hazards, a detailed remediation plan, and a retrospective review of