FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

The FDA issued a warning letter dated July 18, 2025, to Johnson & Johnson’s subsidiary Janssen Vaccines over significant quality control violations at its Incheon, South Korea plant13.

Key issues included failure to thoroughly review complaints and product defects, especially after recurring issues with faulty vial stoppers between November 2023 and November 2024, and staff not escalating or taking sufficient action on these complaints1.

The facility did not conduct a comprehensive assessment of how stopper defects could impact product stability and human use1.

FDA cited that the quality control department failed to submit regulatory notifications consistently for defective products, and did not adequately investigate batch discrepancies or failed specifications1.

The FDA is requesting a comprehensive assessment of the plant’s complaint investigation system and a retrospective review of all complaints from the past three years1.

A J&J spokesperson stated that the company is committed to addressing the FDA’s concerns and insisted the issues are not related to product safety or efficacy, also noting the site no longer produces vaccines1.

This FDA action comes as J&J is expanding manufacturing in the U.S., with recent multi-billion dollar investments in domestic production capabilities1.

Sources:

1. https://www.biospace.com/business/fda-hits-j-j-with-warning-letter-over-significant-violations-at-korean-production-plant

3. https://www.fiercepharma.com/manufacturing/fda-hands-warning-letter-jj-vaccine-subsidiary-over-stopper-issues-spotty-reporting