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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Fresenius Medical Care AG & Co. KGaA

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 820.100(a). Specifically, your Corrective Action and Preventive Action, Procedure No. S100016-03, Rev E. Dated January 30, 2023, is inadequate in that:

Passage 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). Specifically:

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 806
  • 21 CFR 806.10(b)
  • 21 CFR 820.100(b)
  • 21 CFR 820.30(g)