483
Somavac Medical Solutions Inc.Somavac Medical Solutions Inc. – FDA 483, Sep 22, 2023
Record Details
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.
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ID · b83b0a81-7feb-4aa3-9ee5-f346e4e45dc2
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