FDA Warns Fresenius Kabi Over Sterile Injectable Contamination

FDA issued a warning letter to Fresenius Kabi USA on September 22, 2026, citing current good manufacturing practice (cGMP) violations at the company's sterile injectable plant in Melrose Park, Ill., that FDA said left drug products adulterated.¹ The letter follows an FDA inspection of the facility conducted from January 27 to February 18, 2026, and comes after patients reported adverse reactions linked to a contaminated batch.

What violations did FDA identify at the Melrose Park facility?

FDA cited Fresenius Kabi for failing to adequately investigate manufacturing discrepancies, for inadequate aseptic process simulations, and for an insufficient visual inspection program, all in violation of Code of Federal Regulations Title 21, Parts 211.192, 211.113(b), and 211.110(a)/211.42(c)(10).¹ Inspectors found that media fill failures occurred on multiple aseptic filling lines with limited barrier protection in 2024 and 2025 and that the company's investigations blamed operator technique without examining why its aseptic observer program failed to catch the lapses.¹ FDA also documented at least 9 incidents of extrinsic biological contamination, including hair, in production areas dating back to May 2022, and found the firm's visual inspection systems often fell well below the recommended 70% probability of detection for particulates.¹

How did the violations affect patients and lead to recalls?

In 2025 and 2026, Fresenius Kabi received reports of patients experiencing pyrogenic reactions after receiving famotidine injection, which FDA said the company failed to adequately investigate despite repeated bioburden action-limit failures during manufacturing.¹ Retesting of retained samples later confirmed an endotoxin failure, and the company recalled 3 famotidine injection batches. Separately, following a July 9, 2026, recall discussion with FDA, Fresenius Kabi initiated recalls of 6 additional batches on July 16, 2026, covering glycopyrrolate injection, USP; lidocaine HCl injection, USP; and ropivacaine hydrochloride injection, USP, after inspectors found products contained biological particulate matter.¹

What does the Melrose Park facility produce?

The Melrose Park campus is a 430,000-square-foot sterile manufacturing site that produces roughly 250 finished parenteral products, including biologics, small molecules, emulsions, and high-potency compounds, using 6 aseptic filling lines and 6 lyophilizers.² Fresenius Kabi completed a more than $250 million expansion of the site that added integrated aseptic filling lines and lyophilizers, lifting output to more than 160 million vials annually for the US and Canadian markets.² The warning letter separately directs the company to detail its plan for shifting production from older, limited-barrier aseptic lines to newer manufacturing lines, though FDA redacted specifics on which lines are involved.¹

How does this fit the broader pattern FDA has flagged in sterile manufacturing?

The violations echo concerns FDA officials raised recently at the PDA/FDA Joint Regulatory Conference 2026 earlier in September. Jason F. Chancey, PharmD, a consumer safety officer in FDA's Center for Drug Evaluation and Research (CDER) Office of Compliance, described recurring aseptic processing deficiencies tied to cleanroom design and operator behavior in facilities using limited-barrier protection, and flagged behavioral and design lapses as common inspection findings industrywide.³ Jill Furman, JD, director of CDER's Office of Compliance, separately told conference attendees that FDA has observed a rise in facility-design-related violations among manufacturers that have not kept pace with current sterile manufacturing standards.⁴

What are the limitations?

Fresenius Kabi's warning letter is heavily redacted, and FDA has not disclosed which specific manufacturing lines the agency wants the company to abandon. The letter represents FDA's enforcement position, not a final legal determination, and the company has 15 business days from receipt to respond. Its full corrective action plan has not been made public.

References

1. FDA. Fresenius Kabi USA LLC. MARCS-CMS 733107. Warning letter. Published September 22, 2026. Accessed October 1, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-kabi-usa-llc-733107-09222026
2. Fresenius Kabi. Melrose Park, USA. Accessed October 1, 2026. https://cmo.fresenius-kabi.com/sterile-pharmaceuticals/pharmaceutical-sites/melrose-park-usa
3. Mirasol F, Chancey JF. FDA highlights aseptic processing pitfalls at PDA/FDA Conference. BioPharm International. Published September 16, 2026. Accessed October 1, 2026. https://www.biopharminternational.com/view/fda-aseptic-processing-pitfalls-pda-fda-conference
4. Mirasol F, Amatrudo V, Furman J. CBER, CDER compliance leaders outline 2026 guidance shifts and rising GMP violations. BioPharm International. Published September 17, 2026. Accessed October 1, 2026. https://www.biopharminternational.com/view/cber-cder-compliance-leaders-2026-guidance-gmp-violations