FDA 483 - Fresenius Medical Care Holdings, Inc. - September 06, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 47a3da1b-5338-4046-a547-70d68385582d