Janssen’s Korean facility cited for GMP violations

Editor’s Note: This article has been updated with comments from Janssen.

The US Food and Drug Administration (FDA) has cited Janssen for failing to comply with its current good manufacturing practices (CGMP). The agency said the company’s quality unit (QU) did not perform its duties to ensure products complied with manufacturing requirements and failed to properly investigate issues in its manufacturing process.

Last November, FDA inspectors investigated Janssen's manufacturing facility in Incheon, South Korea, and found serious CGMP violations. They noted that the company, a subsidiary of Johnson and Johnson, failed to adequately investigate discrepancies and batch failures at the site and issued a warning letter published on 23 September.

FDA said Janssen received complaints about issues with stoppers on certain products between November 2023 and 2024. However, after an investigation, it failed to identify the issue that led to the problem. The company concluded that its manufacturing process was validated and able to meet specifications.

“However, the investigations did not include a comprehensive assessment of human use, manufacturing, and stability factors that could increase the risk of stopper [redacted] during use,” said FDA. “In addition, you did not always sufficiently pursue collection of relevant samples of vials from complainants.”

While Janssen ultimately conducted an assessment that found several human use factors that could have led to the manufacturing issue, FDA said it did not adequately investigate other potential human use factors that may have contributed to the problem. The agency asked the company to conduct a more thorough assessment of the manufacturing issues and provide a detailed action plan to remediate future issues, including a corrective action, and preventive action (CAPA) plan.

FDA also asked Janssen to provide a detailed plan to assess the specific stopper issue and a retrospective review of all complaints associated with that type of stopper from the past three years. Furthermore, it was asked to conduct an independent and comprehensive review of its complaint handling program.

Inspectors also cited Janssen’s QU for failing to do its job. They said the unit failed to ensure the final product complied with CGMP and met identity, strength, quality, and purity specifications.

"Your quality unit does not consistently follow your procedures for the submission of regulatory notification of product quality defects,” said FDA.

For example, FDA noted that, as per its Biological Product Deviation Reports (BPDR) requirements, the QU failed to escalate and report quality and compliance issues that may require notification to a regulatory body. While the company ultimately did file the BPDRs after inspectors visited the facility, the agency said the response was insufficient.

FDA asked Janssen to conduct a retrospective review of product quality complaints for all its products received within the last three years. It was also asked to provide a comprehensive assessment and remediation plan to ensure the QU has the authority it needs.

A Janssen spokesperson told Focus that the company is taking the FDA's observations seriously and is committed to meeting the highest standards of quality and safety.

"We will work closely with the FDA and are confident that we will promptly address the findings," they added. "This does not relate to the safety and efficacy of our products, and we do not expect any interruption to manufacturing or supply."

Warning letter

Janssen’s Korean facility cited for GMP violations

Related topics

Recommended content

Welcome to the new RAPS Digital Experience