Medical device distribution giant Medline was slammed for a second time since April by an FDA warning letter that has chided the company for repeated problems centered on the presence of toxic bacteria in finished products.
The agency said in a warning letter dated May 26 and posted on its website that between June 2023 and August 2025, the company detected bacillus cereus nine times with at least five samples taken since January 2025.
The FDA last inspected Medline’s Waukegan, Illinois, facility between October 6 through 14 last year, finding that the site failed to appropriately investigate any questionable discrepancies or failures related to its components meeting specifications. The site primarily makes surgical and medical procedure trays, as well as surgical packs.
“Your investigations into contaminated drug product samples identified B. cereus in your manufacturing environment,” the agency said. “Multiple investigations since 2023 have determined that (redacted) are a root cause for the B. cereus contamination in your drug products.”
The presence of the bacteria was also found at Medline’s facility in Hartland, Wisconsin, the FDA said.
In the letter, the agency said that after reviewing Medline’s response to a Form 483, it found the company didn’t explain why its previous CAPA (corrective and preventive action) weren’t successful, and that it failed to identify the root causes of the contamination or its source.
“Your response also states that you have not released any drug product batches with failing microbiological test results,” the FDA said. “However, finished product microbiological testing cannot be relied upon as sole justification to release drug product batches, as contamination is not uniformly distributed in a system and any given sample may not be representative of the type or level of contamination.”
Medline was also chided for not having separate of defined areas to prevent contamination, and failing to establish and follow written procedures for cleaning and maintaining equipment.
The rebuke follows a warning letter Medline was hit with in April for its NAMIC brand Angiographic Control Syringes for certain heart procedures that are manufactured at its Glens Falls, New York, site. That warning was precipitated by hundreds of complaints about the device.
The pair of warning letters are a black eye for the company that raised $6.26 billion in December in what was one of the year’s largest IPOs in the medical device sector.