FDA Center for Drug Evaluation & Research Issues Warning Letter to Fresenius Medical Care AG & Co. KGaA
September 02, 2026
September 02, 2026
WASHINGTON, Sept. 2 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Fresenius Medical Care AG and Co. KGaA from its Center for Drug Evaluation and Research:
* * *
Recipient: Ms. Helen Giza, Chief Executive Officer, Fresenius Medical Care AG & Co. KGaA, Else-Kroner-StraBe 1, 61352 Bad Homburg v.d. Hohe, Germany, (b)(4)
Issuing Office: Center for Drug Evaluation and Research (CDER), U . . .
* * *
Recipient: Ms. Helen Giza, Chief Executive Officer, Fresenius Medical Care AG & Co. KGaA, Else-Kroner-StraBe 1, 61352 Bad Homburg v.d. Hohe, Germany, (b)(4)
Issuing Office: Center for Drug Evaluation and Research (CDER), U . . .