FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
Medline Industries’ multi-year struggle to stop the recurrence of bacterial contamination has triggered an FDA warning letter.
The company, which provides medical-surgical products, went public in December in the biggest initial public offering of 2025. Having raised an initial $6.3 billion, Medline added to its haul by upsizing its IPO and selling out the overallotment. Yet regulatory problems followed the financial success, with the FDA hitting two Medline facilities with warning letters in quick succession.
Having published a letter to a Medline medical device facility in March, the FDA shared a notice to one of the company’s drug plants this week. The agency sent the second warning letter in response to issues its staff found during an inspection of a Medline plant in Waukegan, Illinois, in October.
Between June 2023 and August 2025, Medline isolated objectionable microorganisms from finished drug product samples on about nine occasions, the FDA said. The agency added that Medline recovered Bacillus cereus in at least five samples taken from its manufacturing environment since January 2025. B. cereus is a type of bacteria that causes food poisoning.
FDA inspectors found Medline failed to adequately determine the root cause and prevent the recurrence of the repeated contamination incidents. The FDA raised the issue in a Form 483 in January 2025 and at a meeting with Medline last May.
Medline’s investigations into the contamination found B. cereus at another of its plants, the FDA said. The Hartland, Wisconsin facility supplies a bulk product, although the identity of that product was redacted in the letter. The FDA redacted the identity of the root cause of the B. cereus contamination, saying only that multiple investigations since 2023 have determined the source of the problem.
The company suspended production of a drug product in October 2025 and acknowledged that FDA inspectors found gaps in its adherence to corrective actions and quality standards, the agency said. Yet the FDA found the response inadequate because it lacked an explanation for why previous attempts to fix the problem failed. The repeated failures at multiple sites “demonstrate that management oversight and control over the manufacture of drugs is inadequate,” the FDA said.
The agency published the Medline notice in a batch of warning letters that included missives to Aeroflex Industria de Aerosol and Laboratorios Jaloma. An FDA inspection of a Laboratorios Jaloma site in Mexico found the company failed to document microbiology sampling and testing results for components used in its over-the-counter drug products.
Meanwhile, Brazil’s Aeroflex received a warning letter after failing to respond to multiple FDA requests for records and other information. U.S. law prohibits companies from refusing to permit access to any record, leading the FDA to issue the warning.
