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 facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820, and Title 21 CFR Part 806, Medical Devices, Reports of Corrections and Removals.”
These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 820.100(a).
2. Failure to document all activities and their results required under this section (Corrective and preventive action) as required by 21 CFR 820.100(b)
3. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).
4. A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA within 10-working days of initiating such correction or removal, as required by 21 CFR 806.10(b).
For more information, see the link below:
Fresenius Medical Care AG & Co. KGaA – 666791 – 12/04/2023 | FDA
