FDA WARNING_LETTER - Janssen Vaccines Corp., A Johnson & Johnson Company - November 19, 2024

The FDA issued a Warning Letter to Janssen Vaccines Corp., A Johnson & Johnson Company, following an inspection conducted from November 11 to 19, 2024. The letter identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, outlined in 21 CFR parts 210 and 211, rendering the company"s drug product adulterated under the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the company"s failure to thoroughly investigate recurring complaints received between November 2023 and November 2024, specifically concerning stopper issues with an injectable drug. Investigations were deemed inadequate, lacking comprehensive assessments of human use, manufacturing, and stability factors, and failing to consistently collect relevant samples. The FDA stated that revisions to instructions could not substitute for ensuring product quality.

Furthermore, the quality unit failed to consistently uphold its responsibility to ensure CGMP compliance and product quality. This was evidenced by an insufficient escalation and action on multiple stopper-related complaints, leading to a failure in consistently following procedures for timely regulatory notification of product quality defects, such as Biological Product Deviation Reports.

To address these issues, the FDA requires Janssen to provide a comprehensive assessment and remediation plan for its overall system for investigating deviations, discrepancies, and complaints. This includes a detailed plan to further assess the recurring stopper issues, involving comparative analyses of sterilization and container closure system assembly processes, and human use factors. A retrospective review of all stopper complaints from the last three years and an independent review of the company"s complaint handling program are also mandated.