Sofregen Medical Inc.July 31, 2019

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

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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.

Company: Sofregen Medical Inc.
Inspection Date: July 31, 2019
Product Type: Device
Office: Division of Northeast Imports
Person: Sara M. Richardson

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ID · 36b8c415-c7f2-4c64-a734-6a43f0bbe308