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

Source: https://www.globalkeysolutions.net/records/483/somavac-medical-solutions-inc/b83b0a81-7feb-4aa3-9ee5-f346e4e45dc2

> FDA 483 for Somavac Medical Solutions Inc. on September 22, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Somavac Medical Solutions Inc.
- Inspection Date: 2023-09-22
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.globalkeysolutions.net/companies/somavac-medical-solutions-inc/ec8a2c3d-4f90-483b-af78-9a090a84797b

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea