Janssen Vaccines Corp., A Johnson & Johnson Company

Warning LetterOpen

South KoreaIssued Jul 18, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateJul 18, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Janssen Vaccines Corp., A Johnson & Johnson Company
Location: South Korea
FEI Number: N/A
Country: South Korea
Issue Date: July 18, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Janssen Vaccines Corp.'s drug manufacturing facility in South Korea was found to have violated Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in November 2024. The company failed to conduct adequate investigations of recurring complaints regarding stopper defects associated with injection products between November 2023 and November 2024, including instances where multiple vials from the same batch were affected, and did not identify relevant quality issues that could have caused the observed defects. These manufacturing control failures rendered the drug products adulterated under federal law, as the firm's methods, facilities, and controls did not conform to CGMP standards.

Janssen Vaccines Corp., A Johnson & Johnson Company FDA Warning Letter, July 18, 2025