483
Sarstedt IncFDA 483 - Sarstedt Inc - July 02, 2018
Record Details
Sarstedt Inc. in Newton, NC, a medical device manufacturer, received five observations during an FDA inspection. The firm was cited for inadequate documentation of labels in device history records, insufficient change control procedures, and failures in corrective and preventive action processes. These issues collectively indicate a lack of adherence to established quality system regulations for medical device manufacturing.
- Office
- Atlanta District Office
- Person
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ID · 10b46792-dc6d-4b93-9018-15dd456127b3