Fresenius Shares Drop on U.S. Regulator's Warning Letter to Pharma Business

By Joshua Kirby

Shares in Germany's Fresenius closed lower after the U.S. Food and Drug Administration said it alerted the company to what it called serious violations at a U.S. facility.

In a letter dated Sept. 22, the FDA said violations of standards were observed during an inspection at a Melrose Park, Illinois, facility run by the German healthcare company's pharmaceutical unit, Kabi, at the start of the year.

Fresenius Kabi said in response that no patient-safety concerns had been identified and the Melrose Park site remains operational.

"At this time we do not anticipate significant disruptions to the supply of products currently on the market," it said.

Frankfurt-listed shares in Fresenius closed nearly 5% lower at 44.20 euros on Tuesday, paring sharper losses earlier in the day.

The violations alleged by the FDA included contamination by hair, a failure to properly investigate discrepancies in drug batches, and deviations from accepted aseptic practices.

The drugmaker is taking the necessary actions to address the FDA's points "thoroughly and responsibly," it said.

"We take our quality and compliance obligations seriously and are committed to implementing the actions required from regulatory feedback and strengthening our processes accordingly," Kabi said.

Write to Joshua Kirby at joshua.kirby@wsj.com; @joshualeokirby

(END) Dow Jones Newswires

September 29, 2026 12:37 ET (16:37 GMT)