FDA WARNING_LETTER - Fresenius Medical Care AG & Co. KGaA - August 02, 2023

The FDA issued a Warning Letter to Fresenius Medical Care Holdings, Inc. (Fresenius) following an inspection from June 26 to August 2, 2023. Fresenius, a medical device specification developer, is responsible for complaint handling, recall management, and quality system oversight for North American manufacturing of dialysis systems and accessories, including the 2008 Series Hemodialysis Machine.

The inspection revealed that Fresenius's devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820) and Medical Devices, Reports of Corrections and Removals (21 CFR Part 806).

Violations include: 1. Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). 2. Failure to document all CAPA activities and results (21 CFR 820.100(b)). 3. Failure to establish and maintain procedures for validating device design (21 CFR 820.30(g)), specifically not following Design Validation Procedure S100021-13 for retrospective design validation of 2008T, 2008 K, and 2008 K2 Hemodialysis