483
Sofregen Medical Inc.FDA 483 - Sofregen Medical Inc. - July 31, 2019
Record Details
Sofregen Medical Inc. in Medford, MA, was inspected by the FDA from July 29-31, 2019, and received one observation. The inspection revealed a deficiency in maintaining the device master record for their SERI Surgical Scaffold, specifically regarding current labeling. This indicates a moderate compliance issue related to quality system documentation for a distributed medical device.
Open in Dashboard
ID · 36b8c415-c7f2-4c64-a734-6a43f0bbe308