A Johnson & Johnson innovate medicine subsidiary, Janssen Vaccines, landed in hot water with the FDA this summer over a 2024 inspection of the company’s production facility in South Korea.
In a warning letter dated July 18 and posted on the FDA’s website this week, the regulator chastised Janssen Vaccines for inconsistent quality control procedures and failure to follow up thoroughly on product complaints—issues that came to light during an inspection of the J&J subsidiary’s manufacturing site in Incheon, South Korea, between Nov. 11 and Nov. 19 of last year.
The inspection resulted in Janssen Vaccines initially receiving a Form 483, which is a less severe reprimand for production shortfalls. The FDA may follow up with a warning letter if a company does not rectify the issues identified.
“We are committed to meeting the highest standards of quality and safety in the supply of our products. We take FDA observations seriously,” a J&J spokesperson said in an emailed statement. “We will work closely with the FDA and are confident that we will promptly address the findings. This does not relate to the safety and efficacy of our products, and we do not expect any interruption to manufacturing or supply.”
The spokesperson also said that despite still carrying the Janssen Vaccines name, the site in the FDA's letter no longer supports any vaccine development.
The warning letter’s first citation involved Janssen’s failure to properly investigate numerous complaints about a partially redacted issue pertaining to vial stoppers.
“Your investigations, which included review of batch records, did not identify any ‘… relevant issue recorded which might have impacted the product quality and could lead to the investigated defect …,’ and you add that ‘The manufacturing process is in a validated state of control and is capable to consistently meet specifications,’” the FDA said.
The FDA’s public-facing letter did not disclose the details of Janssen’s stopper issue. The agency has dinged drugmakers in the past when particulates have stuck to vial stoppers or stoppers themselves were shedding particulates into vials and drug product.
The FDA went on to suggest that Janssen’s internal probe lacked a “comprehensive assessment of human use, manufacturing and stability factors” that could have contributed to the stopper problem.
“In addition, you did not always sufficiently pursue collection of relevant samples of vials from complainants,” the regulator continued.
The second and final observation in the warning letter related to the same stopper issue but focused its scrutiny on the Incheon facility’s quality unit, which “does not consistently follow your procedures for the submission of regulatory notification of product quality defects,” according to the FDA.
In essence, the quality unit failed to escalate those stopper complaints to the appropriate channels, circumventing the process through which regulators would have been made aware of a potential issue.
“Timely submission of [Biologic Product Deviation Reports] to regulatory authorities facilitates awareness and evaluation of potentially hazardous product defects,” the FDA explained.
The FDA caveated that the company did eventually submit one of those product deviation reports on Dec. 10 and pledged to update its procedures around them moving forward.
But the federal agency argued that Janssen’s response didn’t go far enough, pointing out that the company failed to propose a retrospective review of complaints around marketed products, which would be necessary to pinpoint other instances where a product deviation report should have been submitted.
In turn, the FDA is calling on the company to conduct a “retrospective review of product quality complaints received within the last three years for all Janssen products to identify any circumstances” in which the unit may have failed to properly report deviations at the Incheon site. The regulator also called on Janssen to work out a remediation plan that ensures its Incheon quality unit is “given the authority and resources to effectively function.”
Janssen is also on the hook to further review its overall system for investigating manufacturing issues at the facility, as well as the undisclosed stopper issue, with the FDA specifically calling on the company to examine whether its stopper sterilization process, container closure system assembly process or human use factors could be contributing to the problem.
Stopper problems recently surfaced at a former Catalent plant in Bloomington, Indiana, which Novo Nordisk has taken over following its parent company’s acquisition of the CDMO in late 2024.
In a Form 483 directed at the Bloomington facility, the FDA chided Novo earlier this year for failing to properly follow up on “an ongoing trend” of hair turning up on vial stoppers.
Editor's note: This story was updated at 4 p.m. ET on Sept. 23 to include a statement and further information from Janssen.