FDA 483 - Sofregen Medical Inc. - July 31, 2019

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.