CGMP Violations at Janssen Vaccines S. Korea Plant

An 11/11-11/19/2024 FDA inspection at the Janssen Vaccines drug manufacturing facility in Incheon, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/18 Warning Letter says the specific violations were:

• failure 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 had already been distributed; and
• failure of the firm’s quality unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says Janssen’s responses to the inspection observations were inadequate. The company was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.