Warning letterPosted September 1, 2026
FDA warning letter to Fresenius Medical Care AG & Co. KGaA
CGMP/Finished Pharmaceuticals/Adulterated
FDA posted a warning letter to Fresenius Medical Care AG & Co. KGaA on September 1, 2026; the letter is dated August 25, 2026. Subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Fresenius Medical Care AG & Co. KGaA
- Subject
- CGMP/Finished Pharmaceuticals/Adulterated
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2026-08-25
- Posted by FDA
- 2026-09-01
- Source
- FDA warning letters ↗
CFR cited
The record cites 3 sections of 21 CFR Parts 210 and 211.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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