The U.S. Food and Drug Administration (FDA) has issued a warning letter to Fresenius Kabi USA LLC over significant Current Good Manufacturing Practice (CGMP) violations identified at the company's sterile drug manufacturing facility in Melrose Park, Illinois.
The warning letter, dated September 22, 2026, follows an FDA inspection conducted from January 27 to February 18, 2026. FDA said the inspection identified deficiencies involving investigations, aseptic processing, contamination control, media fills, visual inspection and facility design.
FDA identifies deficiencies in sterile drug manufacturing
According to the FDA, Fresenius Kabi's manufacturing methods, facilities and controls did not conform to CGMP requirements. The agency stated that the drug products manufactured at the facility were considered adulterated under the Federal Food, Drug, and Cosmetic Act.
One of the major findings concerned the company's investigation of manufacturing discrepancies and product failures.
FDA said investigations lacked adequate data-supported root-cause analysis, appropriate documentation, assessment of potentially affected products and effective CAPA follow-up. The agency also said the company had relied too heavily on passing finished-product tests when assessing certain manufacturing problems.
FDA links concerns to famotidine injection
The warning letter states that during 2025 and 2026, Fresenius Kabi received reports of adverse drug events, including apparent pyrogenic reactions, following administration of famotidine injection.
FDA noted that manufacturing of the product had experienced multiple bioburden action-limit failures. Subsequent testing of retained finished-product samples identified an endotoxin failure, and the company ultimately recalled three batches of famotidine injection.
FDA highlighted the importance of controlling endotoxin risks in parenteral medicines because pyrogen contamination can cause serious reactions, including fever, hypotension, inflammatory reactions and, in severe cases, anaphylactic shock or death.
Multiple media-fill failures reported
FDA also identified deficiencies in the company's aseptic processing and media-fill program.
The agency said media-fill failures occurred on aseptic manufacturing lines in 2024 and 2025. According to FDA, the company attributed the failures primarily to operator aseptic technique but did not adequately investigate why its aseptic observer program failed to detect the practices during commercial operations.
FDA further said that some media fills did not adequately represent the maximum number of interventions that could occur during actual aseptic production. The agency also found deficiencies in documentation of interventions and media-fill batch sizes.
FDA cites contamination involving hair and other biological particulates
Another significant concern involved extrinsic biological contamination.
FDA said Fresenius Kabi had documented at least nine incidents of extrinsic contamination, including hair, beginning in May 2022. The agency stated that some contamination was found free-floating or in direct contact with drug products.
FDA also questioned why commercial batches associated with such contamination were not rejected and said the company had not demonstrated that it had adequately examined retained samples of distributed products for the presence of hair.
Visual inspection program also criticized
The FDA identified additional deficiencies in the company's visual inspection program for sterile injectable products.
According to the warning letter, the inspection program did not adequately ensure that products were essentially free of visible particulate matter and other defects. FDA said the company's particulate-detection systems showed inadequate and variable detection performance and that glass particles were not consistently detected.
The agency also cited deficiencies in the classification of non-glass particulate defects and the lack of appropriate defect limits for specific types of particulate matter.
Concerns over facility and aseptic line design
FDA also raised concerns about the design of certain aseptic processing lines and their ability to provide adequate protection of critical ISO 5 areas.
The agency cited frequent interventions, use of equipment and tools during critical aseptic connections, varying barrier configurations and other design-related concerns. FDA said these factors could increase contamination risks during sterile manufacturing.
The agency requested a comprehensive assessment of contamination hazards, including equipment suitability, cleanroom layout, air quality, personnel and material movement, disinfection practices and human interactions within critical processing areas.
Six additional product batches recalled
FDA said it held a teleconference with Fresenius Kabi on July 9, 2026, to discuss voluntary recalls after the inspection identified biological particulate contamination concerns.
Following the discussion, Fresenius Kabi committed to recalling six additional batches. FDA's letter identifies recalls involving:
- Glycopyrrolate Injection, USP
- Lidocaine HCl Injection, USP
- Ropivacaine Hydrochloride Injection, USP
The recalls were initiated on July 16, 2026.
FDA asks Fresenius Kabi for extensive corrective actions
The FDA has requested several independent assessments and remediation plans, including reviews of:
- Deviation, discrepancy and complaint investigations
- Root-cause investigations involving biological particulate matter
- Critical investigations conducted during the previous three years
- The company's CAPA system
- Endotoxin contamination controls
- Environmental monitoring
- Media-fill and process-simulation programs
- Visual inspection systems
- Supplier quality investigations involving stoppers
- Aseptic processing operations and facility design
FDA also recommended that Fresenius Kabi engage a qualified CGMP consultant because of the nature of the violations and what the agency described as repeat violations.
What happens next?
Fresenius Kabi was instructed to submit a written response to the FDA within 15 business days of receiving the warning letter. FDA said unresolved violations could have regulatory consequences, including potential withholding of approvals for new applications or supplements listing the facility as a drug manufacturer, as well as possible reinspection.
The FDA also asked the company to contact its Drug Shortages Staff if corrective actions could disrupt the supply of medicines manufactured at the facility, allowing the agency to assess potential supply implications.
The FDA warning letter is an enforcement communication identifying alleged CGMP deficiencies; it is not, by itself, a final legal determination. Fresenius Kabi remains responsible for addressing the cited deficiencies and demonstrating sustained compliance with FDA requirements.
