FDA Issues Warning Letter to Janssen Vaccines Corp. for CGMP Violations

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Janssen Vaccines Corp., a Johnson & Johnson Company, following a November 2024 inspection of its South Korean manufacturing site. The FDA identified significant violations of current Good Manufacturing Practice (CGMP) regulations for drug products.

Key findings include failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192) and inadequacies in the quality unit’s oversight to ensure products meet specifications for identity, strength, quality, and purity (21 CFR 211.22). Investigations of recurring complaints regarding packaging materials were insufficient, lacking comprehensive assessment of human use, manufacturing, and stability factors.

The FDA’s Warning Letter mandates extensive corrective and preventive actions (CAPA). Noncompliance may result in refusal of new submissions or supplements and potential re-inspection to verify CGMP adherence.

The full list of violations and the FDA’s conclusions are detailed in the Warning Letter for Janssen Vaccines Corp., a Johnson & Johnson Company.

06-10-2025