# FDA 483 - Variamed, LLC - December 18, 2024

Source: https://www.keypedia.com/records/483/variamed-llc/367f794b-7d83-4f45-80ac-8e5bf1e7f2e7

> FDA 483 for Variamed, LLC on December 18, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Variamed, LLC
- Inspection Date: 2024-12-18
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Variamed, LLC in Chattanooga, TN, a specification developer of Class I and Class II medical devices, received a Form FDA-483 with 12 observations. The inspection revealed a severe lack of fundamental quality system procedures, including design control, purchasing, CAPA, complaint handling, medical device reporting, and unique device identification requirements. These deficiencies indicate a comprehensive failure to establish and maintain a compliant quality system.

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)
- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/variamed-llc/9d0d363b-2931-40e7-9591-b44d022f4e9f

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