FDA 483 - Janssen Vaccines Corporation - November 19, 2024

This FDA Form 483 was issued to Janssen Vaccines Corporation, a drug product manufacturer located at 23 Haimon-ro 303 Beon-gil, Yeonsu-gu, Incheon 22014, Republic of Korea (South), following an inspection from November 11-19, 2024. The General Manager, John Yi, was the recipient.

Five observations were noted:

1. **Quality Unit Procedures:** Responsibilities and procedures for quality units were not in writing or followed to ensure Field Alert Reports (FARS/BPDR) were submitted for distributed products with quality issues. Specifically, the firm failed to follow its procedure TV-WI-21853 Version 29.0 for FARS/BPDR submission, which requires reporting for two or more complaints with the same confirmed defect/root cause for the same finished good lot or common component lot. Between November 13, 2023, and November 8, 2024, at least 25 market complaints for stopper issues were recorded for a specific product, with multiple complaints for the same lot numbers. The firm's investigation concluded the issue was not manufacturing-related, and no CAPA was implemented.

2. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products were not established or followed. * On November 13