The issues the regulator found include the failure to comprehensively review complaints and product defects.
The FDA has issued a warning letter to Johnson & Johnson’s subsidiary Janssen Vaccines, flagging lapses in quality control and the failure to follow good manufacturing practices at a production plant in South Korea.
The letter, dated July 18, was made public on the FDA’s website on Tuesday; it noted that the facility’s quality control department “does not consistently follow your procedures for the submission of regulatory notification” for defective products. In particular, after receiving a couple of complaints about faulty vial stoppers in its products, officers in charge did not escalate the matter to the appropriate authorities, nor did they take “sufficient action” on these complaints.
The South Korean plant, located in Incheon, also did not “thoroughly investigate” discrepancies or failures of batches that failed to meet specifications. Between Nov. 13, 2023 and Nov. 8, 2024, the facility received “recurring complaints” regarding its vial stoppers, and while officers reviewed batch records, they failed to conduct a “comprehensive assessment” of how these stopper problems could affect human use and the stability of its products, as per the warning letter.
In response to these issues, the FDA is requesting information from J&J, including a “comprehensive assessment” of the plant’s system for investigating complaints and product defects, as well as a retrospective review of all complaints over the last three years, to help identify other reporting lapses.
In a statement to Fierce Pharma on Tuesday, a spokesperson for J&J said that the pharma is “committed to meeting the highest standards of quality and safety in the supply of our products.” Nevertheless, the spokesperson insisted that these observations do “not relate to the safety and efficacy of our products,” noting that the South Korean site in the FDA’s report no longer produces vaccines.
“We take FDA observations seriously,” the spokesperson said, adding that the pharma is “confident” that it can address the FDA’s concerns “promptly.”
The concerns at J&J’s South Korea plant come as the pharma undergoes a massive domestic manufacturing push. In March, in response to the threat of tariffs from President Donald Trump, J&J announced that it would invest $55 billion into production and R&D capabilities in the U.S., which will be disbursed over the next four years. Then, in August, the pharma added $2 billion to the commitment as part of a 10-year agreement with Fujifilm to construct a 160,000-square-foot facility in North Carolina.
