FDA 483 - Somavac Medical Solutions Inc. - September 22, 2023

Scmavac Medical Solutions Inc. in Bartlett, TN, was inspected from September 19-22, 2023, revealing critical deficiencies in record management. The firm was found to be destroying original wet signature records after digital upload to an unvalidated server, and was unable to locate a crucial page for a complaint record. These findings indicate serious concerns regarding data integrity and the firm's compliance with record retention regulations.