FDA warns drugmakers for GMP and BIMO violations, records refusal
The US Food and Drug Administration (FDA) recently sent warning letters to two facilities in the United States and Mexico for failing to comply with current good manufacturing practices (cGMPs) related to contamination issues and data integrity problems. The agency also warned a company in Brazil for failing to respond to a request for written records and to a laboratory in the US for nonclinical study violations.
Medline failed to address multiple contamination incidents
Medline, Inc received a warning letter for repeated failures to address contamination and other GMP violations at its Waukegan, IL facility. FDA also reprimanded the company for having similar contamination problems at its site in Hartland, WI. The company is a large supplier of medical and surgical products and products for advanced wound care.
FDA reported that between June 2023 and August 2025, the company found objectionable microorganisms, specifically Bacillus cereus, in finished drug product samples on nine separate occasions. Additionally, since January 2025, the company has identified five more samples of products that tested positive for Bacillus cereus.
In addition, manufacturing operators “engaged in practices that pose significant contamination risk” for drugs, such as using cleaning tools without suitable gloves.
The letter states that “these repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.”
Laboratorios Jaloma cited for data integrity problems
FDA issued a warning letter to Laboratorios Jaloma S.A., an over-the-counter (OTC) drug manufacturer in Guadalajara, Mexico, due to data integrity violations in the microbiology lab. The warning letter states that the company’s “laboratory records did not accurately reflect activities performed. For example, your microbiologist documented the collection of routine [redacted] samples, but after questioning, your microbiologist admitted that the samples were never actually taken.”
Furthermore, the microbiologist acknowledged consistently conducting colony counts after incubation, instead of adhering to established procedures. The warning letter states that the “firm’s actions represent a critical breakdown in your laboratory controls and undermine the integrity of your data.”
FDA investigators also found that the company failed to exercise appropriate controls over its computer systems to ensure that only authorized personnel instituted changes in master production and control records.
FDA placed all drugs from the facility on an import alert in April 2026.
HealthPartners failed to use correct analytical methods
FDA sent a warning letter to HealthPartners Neuroscience Center Research and Innovation in Saint Paul, MN for “objectionable conditions” following a nonclinical laboratory inspection conducted as part of FDA’s Bioresearch Monitoring Program.
In the warning letter, the FDA indicated that the management of the testing facility failed to ensure tests were conducted using appropriate analytical methods to evaluate the mixture's uniformity.
The protocol and final study report for one study indicated that the test article was dissolved in sterile water to achieve final dose concentrations of 1%, 10%, or 20%, or equivalent to 0.5 mg, 5 mg, and 10 mg, respectively. For another study, the final dose concentrations were also set at 1%, 10%, or 20%, which corresponded to 2 mg, 20 mg, and 40 mg. However, after reconstituting the test article with sterile water to the specified final dose concentrations, the testing facility did not conduct appropriate analytical tests to assess the uniformity and concentration of the resulting mixtures prior to dosing all animals in studies.
FDA said the company’s quality assurance unit failed to review the final study report to assure that the reported results accurately reflect the raw data of the nonclinical laboratory study. For example, the study report did not record the deaths of two male rats. Also, the testing facility management failed to ensure that equipment used to analyze the blood of rat and rabbit species for the protocol-required hematology and serum chemistry laboratory tests was adequate.
Aeroflex refused record requests
Aeroflex Industria de Aerosol, an OTC drug maker located in Curitiba, Brazil, received a warning letter for not responding to several regulatory requests for records. A request made in October 2025 went unanswered, along with multiple follow-up requests.
The letter states that until FDA confirms compliance with current GMPs, the agency may delay or withhold approval of any new applications or supplements listing the firm as a drug manufacturer.
