Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1713747.
Violations3
Issue DateAug 25, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Fresenius Medical Care AG & Co. KGaA
Location
Else-Kröner-Straße 1 61352 Bad Homburg v.d. Höhe Germany, (b)(4)
FEI Number
1713747
Country
Germany
Issue Date
August 25, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
CGMP/Finished Pharmaceuticals/Adulterated
Fresenius Medical Care AG & Co. KGaA FDA Warning Letter, August 25, 2026
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