Fresenius Medical Care, North AmericaMay 21, 2021

FDA 483 - Fresenius Medical Care, North America - May 21, 2021

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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.

Company: Fresenius Medical Care, North America
Inspection Date: May 21, 2021
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Saied A. Asbagh (Investigator)

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ID · e6d7cf63-c9b4-419b-8dad-1febdcab29cf