FDA warns Baxter, Olympus for GMP and QSR violations
The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter International and Olympus Medical Systems—for good manufacturing practice (GMP) and Quality System Regulation (QSR) violations.
Both warning letters note that the firms were cited for repeat observations from previous interactions with the agency.
Baxter International
FDA inspected Baxter’s Round Lake, IL facility last spring and found multiple problems tied to the manufacturing of sterile drug products, including the beta-lactam antibiotic cephalosporins. The warning letter points out that some of the problems were not adequately addressed despite having previously been raised with the company.
Baxter’s Round Lake facility makes sterile injectables, ready-to-use premixed drugs in proprietary bags, plasma-derived therapies, and antibiotics.
During the inspection, investigators found that Baxter failed adequately prevent cephalosporin contamination in other parts of the facility. FDA investigators said that despite a wall separating its cephalosporin manufacturing from areas where other drugs are made, cephalosporin was found in multiple areas of the buildings going back to January 2025.
FDA said that contamination of non-beta-lactam drugs with cephalosporins “presents a serious risk to patient safety” including potentially life-threatening exposures in susceptible patients. The letter notes that “no safe level of beta-lactam contamination has been determined to be a tolerable risk.”
Another issue involved the failure to create and adhere to suitable written procedures for preventing microbiological contamination. Investigators noted that the company's acceptance criteria were inappropriate because they permitted the routine recovery of multiple biological indicator survivors during each re-qualification run. These indicator survivors are a statistical and validation approach used in sterilization microbiology.
FDA pointed out that the company has a “history of sporadic sterility test positives since 2013” pointing to “persistent particulate contamination issues.”
Additionally, the operators responsible for visual inspection were not properly qualified to inspect cefazolin. For instance, they were not adequately tested to ensure their ability to detect particles at the lower end of the visible spectrum.
The “significant” number of complaints regarding particulate matter received between 2023 to 2025 suggests that the visual inspection program is inadequate.
The company also failed to adequately investigate out-of-specification results. “There was a pattern of inadequate investigations into critical issues, including leaking drug products and sterility failures,” FDA said.
The FDA chastised the firm for not learning from its earlier mistakes. “In a previous regulatory meeting held on January 15, 2025, FDA discussed similar CGMP violations at this facility. You proposed specific remediations for these violations in your response. FDA also cited similar CGMP violations at other facilities in your company’s network. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.”
Similar GMP sterility problems were cited in a warning letter FDA issued to one of Baxter’s sites in India in 2023. (RELATED: FDA warns Intas, Centaur and Baxter over GMP violations at Indian facilities, Regulatory Focus 2 August 2023)
FDA advised the company to hire a consultant to help it meet its GMP requirements. FDA also recommended the company arrange a teleconference to discuss its remediation plan.
Olympus Medical Systems
FDA sent a warning letter to Olympus following inspections at six of its facilities in October and November 2025—four in Japan, one in the United States, and one in Germany. The inspections identified various QSR and medical device reporting (MDR) violations. Olympus manufactures a range of surgical and endotherapy devices, including hemostatic metal clips, sphincterotomes, cystoscopes, bronchoscopes, endoscopic distal covers, valves, and insufflators.
FDA noted in the warning letter that while the inspections were conducted under the QSR, the company’s corrective actions must be made in compliance with the Quality Management System Regulation (QMSR), which took effect earlier this year.
At the Shirakawa facility in Japan, the company failed to identify and control known “catastrophic hazards,” and its risk management report did not address these hazards associated with its UHI-4 insufflator, which include air embolism, arrhythmia, and a patient death.
Similarly, at the Aomori site in Japan, the company did not identify or evaluate known hazards in the risk management documentation. Additionally, it did not implement risk control measures for the manufacturing processes of the sphincterotome.
At the company's facility in Brooklyn Park, MN, nonconforming Vizishot 2 FLEX (19G) devices were reworked and distributed without sufficient justification that the rework addressed the root cause of the nonconformance.
Additionally, there were violations related to MDRs identified during the inspection at the Brooklyn Park facility. The company had 54 open quality plans open, “including multiple plans intended to address backlogs in the complaint system and late MDRs.”
The same day the warning letter was issued, on 20 October, FDA issued an import alert covering multiple devices made by the company, including ureterorenoscopes, bronchoscopes, laparoscopes, automated endoscope reprocessors, ingestible telemetric gastrointestinal capsule imaging systems, and enteroscopes.
In the warning letter, FDA described recurring quality system failures.
“In response to three prior warning letters issued to your firm in 2022 and 2023 (including the Hachioji and Hinode facilities), your firm implemented new global procedures, including complaint handling, MDR, and CAPA procedures. Review of these procedures found the roles and responsibilities of manufacturing sites versus your global remote corporate entity have not been clearly defined, including, for example, how your firm will assess that site specific quality issues have been resolved, and how your global CAPA process will provide oversight and ensure correction and prevention of repetitive quality issues within and across your global facilities that follow these procedures,” FDA wrote.
FDA flagged similar previous problems with the company in two warning letters issued to Japanese sites in late 2022. (RELATED: FDA warns endoscope maker Olympus over quality system, device reporting issues, Regulatory Focus 11 January 2023)
