FDA Hits Fresenius Kabi With Second Warning Letter

FDA has warned Fresenius Kabi USA over sterile-manufacturing failures at its injectable drug plant in Melrose Park, Illinois — a facility large enough to produce roughly 250 finished parenteral products — after an inspection tied to patient reports of pyrogenic reactions to the company's famotidine injection. The September 22 letter does not describe a single lapse. It describes a pattern: contamination findings the agency says the site has documented, and not adequately corrected, for years.

How the contamination surfaced

The sequence FDA lays out starts with routine batch-release testing that found nothing wrong. Famotidine injection lots manufactured at Melrose Park cleared standard bacterial-contamination testing before release. It was only after patients receiving the drug reported pyrogenic reactions — fever-type responses consistent with endotoxin exposure — that follow-up testing identified endotoxin contamination the original release testing had missed. Fresenius Kabi recalled three lots of the famotidine injection as a result. FDA's letter frames that gap as more than a one-off miss: the agency's core citation under 21 CFR 211.192 is that the firm's investigation into the underlying cause was not thorough enough to prevent a recurrence, a standard that looks past the specific contaminated batches to whether the facility's root-cause process is reliable at all.

A finding the plant has seen before

The detail most likely to concern a quality-systems reviewer is not the famotidine contamination itself but FDA's accounting of hair contamination at the site: nine separate documented instances in aseptic processing areas, with the earliest dating to May 2022. A single contamination event in a sterile facility is a deviation to investigate. Nine instances of the same category of lapse spanning more than three years is, in FDA's framing, evidence that the facility's corrective actions after earlier findings did not actually close the gap — precisely the CAPA-adequacy question that separates a contained incident from a systemic quality-system failure. The letter pairs that history with media-fill failures on the plant's limited-barrier production lines in 2024 and 2025, which Fresenius Kabi's own response attributed to operator technique. FDA's objection is less to that explanation than to what didn't follow it: the company had not adequately assessed whether its aseptic-observation program was actually capable of catching those technique lapses before they reached product, rather than explaining them away after the fact.

What the letter requires, and the group context

• FDA's letter calls for a comprehensive, independent assessment of the facility's CAPA program and visual-inspection program, with the firm's response and corrective-action plan due within 15 business days of the letter.
• Unresolved violations carry the agency's standard warning-letter consequences: potential withholding of approval for new applications or supplements that list Melrose Park as a manufacturing site, and the likelihood of re-inspection before those sanctions would be lifted.
• Trade coverage (FiercePharma) describes this as the second warning letter to a Fresenius-group facility within roughly a month; Regulatory News reviewed that characterization but could not independently confirm the identity, date, or citations of the earlier letter from a primary FDA source, and is not naming a specific first facility here.
• Fresenius Kabi has drawn FDA warning letters at other sites in past years, including facilities outside the U.S.; this letter does not reference that history, and nothing in FDA's September 22 letter ties Melrose Park's findings to any other site's quality system.

For a sterile-injectables manufacturer, the practical read of this letter is less about the famotidine recall — a contained, already-executed correction — and more about what nine hair-contamination findings over three-plus years signal to FDA about the facility's underlying investigation and CAPA discipline. That is the finding most likely to shape how much scrutiny Melrose Park's next pending application or supplement draws, independent of whatever the firm's 15-business-day response says about the famotidine lots specifically.

Frequently asked questions

What did FDA cite, and where?

A warning letter dated September 22, 2026 to Fresenius Kabi USA, LLC, covering its sterile-injectable manufacturing facility in Melrose Park, Illinois (FEI 1450022), a roughly 430,000-square-foot site producing about 250 finished parenteral products. The letter followed an FDA inspection conducted January 27 to February 18, 2026 and cited violations of 21 CFR 211.192 (failure to thoroughly investigate discrepancies and failures), 211.113(b) (inadequate procedures to prevent microbiological contamination of sterile products), and 211.110(a)/211.42(c)(10) (deficient in-process controls and visual-inspection program).

What triggered the inspection and the famotidine recall?

Patients reported adverse pyrogenic reactions associated with Fresenius Kabi's famotidine injection, 20 mg/2 mL. Initial batch-release testing had cleared the lots of bacterial contamination, but testing prompted by the complaints found endotoxin contamination. Fresenius Kabi recalled three affected lots; FDA's letter also names glycopyrrolate, lidocaine HCl, and ropivacaine HCl injections among products manufactured at the site.

What else did the letter flag?

FDA documented nine separate instances of hair contamination in aseptic processing areas, the earliest dating to May 2022 — a recurring finding FDA said the facility had not adequately root-caused or corrected over several years, alongside unresolved media-fill failures on limited-barrier production lines in 2024 and 2025 that Fresenius Kabi attributed to operator technique without adequately assessing its own aseptic-observation program's ability to catch such lapses.

Is this really the company's second warning letter in a month?

Trade outlet FiercePharma reported this as the second warning letter to a Fresenius-group facility within roughly a month, without naming the earlier site in the coverage Regulatory News reviewed. Regulatory News could not independently verify the identity or date of that first letter from primary FDA sources and is not asserting it here beyond that single trade-press characterization.