Day

December 4, 2023
04
Dec

Warning Letter- Not Conforming to Manufacturing Requirements

December 4, 2023
Fresenius Medical Care AG & Co. KGaA was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: “This inspection revealed that the above devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the...
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