FDA 483 - Fresenius Medical Care Holdings, Inc. - September 06, 2019

An FDA inspection of Fresenius Medical Care Holdings, Inc. in Waltham, MA, a medical device manufacturer, revealed significant deficiencies in their quality system. The inspection identified issues primarily related to inadequate design control procedures, including failures in design input, output, verification, and validation for their CombiSet with Priming Set SMARTECH device. Additionally, the firm's corrective and preventive action procedures were found to be inadequately established and implemented.