483
Fresenius Medical Care, North AmericaFresenius Medical Care, North America – FDA 483, May 21, 2021
Record Details
An FDA inspection of Fresenius Medical Care, North America in Ogden, UT, from May 19-21, 2021, revealed a significant deficiency in the firm's investigation processes. The company failed to conduct comprehensive investigations into numerous patient complaints regarding leakage of their Delflex Peritoneal Dialysis Sterile Solution bags. This indicates a serious lapse in quality control and root cause analysis for a critical medical product.
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