US FDA Warning Letter: Inadequate Investigation of Complaints

The U.S. FDA issued now a Warning Letter (WL) to the South Korean company "Janssen Vaccines Corp., A Johnson & Johnson Company" after having inspected its site in November 2024.

The significant violations of CGMP regulations for drug products, which are mentioned in the Warning Letter, are listed as follows:

• "Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)."
• "Your firm's quality unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22)."

According to U.S. FDA Warning Letter, the firm failed to do "adequate investigations of recurring complaints" related to their finished products' packaging materials, even so these complaints occurred more than one time. As mentioned in the Warning Letter, "the investigations did not include a comprehensive assessment of human use, manufacturing, and stability factors…".
The observed findings resulted in a long list of remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA may refuse approval of new submissions or supplements and may re-inspect the company to ensure CGMP compliance.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Janssen Vaccines Corp., A Johnson & Johnson Company.