Injectables juggernaut Fresenius Kabi has been hit with an FDA warning letter, the second for the Fresenius group in less than a month.
The regulator’s latest censure zeroes in on Fresenius Kabi’s sterile injectables facility in Melrose Park, Illinois, a suburb of Chicago. The letter, dated Sept. 22 and posted to the agency’s website this week, follows an FDA inspection of the site from Jan. 27 to Feb. 18 of this year.
The FDA’s primary concerns with the facility were three-fold: a failure to investigate batch inconsistencies, a failure to establish and follow procedures that prevent microbial contamination of would-be sterile products, and inadequate quality control systems.
Between 2025 and 2026, the FDA noted that patients reported adverse reactions to Fresenius’ famotidine injections, a reflux and heartburn treatment.
The FDA’s inspection revealed that Fresenius released the batches despite warning signs that they were contaminated. Per the write-up, Fresenius was overreliant on final batch testing, which initially cleared the batches of bacterial contamination. But further testing after the customer complaints revealed the injections were contaminated with endotoxins left over from the microbes. Fresenius ultimately recalled three batches.
While Fresenius agreed to do more endotoxin testing moving forward, the FDA said that approach misses the point. The agency called for the manufacturing unit to focus on its larger systemic issues, including its complaint handling system and its corrective and preventative actions (CAPA).
The FDA also highlighted nine different instances of hair contamination at the facility, starting in May 2022. “This contamination was described as free-floating and in direct contact with the drug product," the FDA said. "Drug products contaminated with hair can have microbial contamination and are generally considered adulterated. You did not initiate timely investigations in response to this contamination,” the agency wrote.
Due to the ongoing nature of the violations, the FDA recommended Fresenius Kabi take on a current good manufacturing practice (cGMP) consultant to help the plant course correct.
The warning letter follows a summer of multiple recalls for Fresenius Kabi. In July, contamination found by the FDA prompted recalls for three injectables: glycopyrrolate, lidocaine HCl, and ropivacaine hydrocholoride. Then, in August, the drugmaker voluntarily recalled one lot of mislabeled morphine sulfate less than a week before recalling a batch of its biosimilar Tyenne due to contamination with glass particulates.
Sister company Fresenius Medical Care, which specializes in renal care and dialysis, was dinged with its own warning letter in late August, citing concerns at its plant in Ogden, Utah.