FDA Issues Warning Letter to Janssen Vaccines Korea Facility Over CGMP Violations

During this inspection, the FDA found that JanssenHandling Product Defects, Complaint Investigations, and Quality ManagementThere are prominent issues in this aspect.

First, inDrug Quality Complaints and Deviation InvestigationsIn this aspect, Janssen failed to conduct a thorough investigation into the recurring defects related to medicine bottle stoppers. Although the company claimed during the investigation that the production process was under control and consistently met quality standards, the scope of the investigation was actually limited. It did not deeply analyze potential human operation factors during the medicine usage process, nor did it comprehensively examine the impact of production and stability conditions on stopper defects.

In addition, the companyFailure to collect and evaluate complaint samples in a timely and adequate manner, leading to insufficient traceability of the defect causes. The FDA pointed out that Janssen's revision of the package insert to alert users about the associated risks cannot replace the fundamental responsibility of ensuring the quality and safety of the drug throughout its shelf life.

Secondly, the FDA criticized JanssenThe Quality Department Neglected Its Regulatory DutiesThe company’s procedures require timely reporting upon discovering any situation that may affect product quality. However, between 2023 and 2024, when multiple batches of products received two or more similar complaints regarding bottle stoppers, the responsible personnel failed to report according to internal procedures. They also did not submit a Biological Product Deviation Report (BPDR) to regulatory authorities in a timely manner. It was not until December 2024 that Janssen finally submitted the relevant report. The FDA emphasized that delayed reporting could impede regulatory responses to potential product risks, endangering medication safety.

FDA requires Janssen to submit a written corrective action plan within 15 working days after receiving the warning letter, detailing the improvement plans for the complaint investigation system, the functions of the quality management department, and risk assessment and corrective preventive measures. Meanwhile, the FDA also requests the company to conduct a retrospective review of relevant complaints over the past three years to evaluate whether there are any instances of failure to report as required.

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