Janssen Vaccine Unit Warning Letter Flags Complaint Handling, Regulatory Notifications

Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA warning letter citing significant lapses in complaint investigation and regulatory reporting. The Janssen (FEI 3012637764) site was inspected by USFDA investigator Rajiv R Srivastava in November 2024.

Complaint Investigations

Investigation of recurring complaints about stopper defects in injectable drug vials were not thorough. Batch record reviews failed to identify probable causes, and the Firm concluded the process was under control. Investigations lacked a comprehensive assessment across human use, manufacturing, and stability factors. Also, Janssen did not pursue collection of relevant samples from complainants. FDA has asked Janssen to perform a comprehensive assessment of systems for investigating deviations and complaints, and also comprehensively assess complaints of all stopper complaints of last 3 years.

Failure of Quality Unit (QU) Oversight, Failure to file regulatory notifications

QU failed to exercise its responsibility to ensure compliance with cGMP, did not follow procedures for regulatory notification of product defects. Multiple complaints across batches were not escalated or Biological Product Deviation Reports (BPDRs) not filed. The procedure for regulatory notifications required recurring complaints to be reported only when product quality is not meeting manufacturing standards. FDA observed the Firm’s response for updating procedures for regulatory notifications was inadequate. FDA has asked Janssen for a retrospective review of all complaints received within last 3 years and also remediation plan to ensure the Quality Unit is given authority to effectively function.

The Warning Letter underscores the importance of a Product Life Cycle Approach to cGMP systems and controls – ensuring product quality and integrity not only during manufacturing, but across storage, shelf life, and end-use.

Janssen Warning Letter (July,2025)