# FDA 483 - Somavac Medical Solutions, Inc. - June 24, 2021

Source: https://www.keypedia.com/records/483/somavac-medical-solutions-inc/90720aed-a578-4ac4-b6d2-d33b85963764

> FDA 483 for Somavac Medical Solutions, Inc. on June 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Somavac Medical Solutions, Inc.
- Inspection Date: 2021-06-24
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Somavac Medical Solutions, Inc. in Memphis, TN, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, lacking investigation plans and proper documentation. Additionally, issues were noted with design validation procedures, specifically regarding the inclusion and execution of intended use validation for their SOMAVAC device.

## Related Officers

- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)
- [investigator](https://www.keypedia.com/people/mary-kay-concannon/83975c71-f8c5-48f7-926d-84f934e73cb6)

Company: https://www.keypedia.com/companies/somavac-medical-solutions-inc/bdbe031c-156d-44ab-9b7a-431d91e04146

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