# FDA 483 - Cumberland Biotherapeutics LLC - June 27, 2024

Source: https://www.keypedia.com/records/483/cumberland-biotherapeutics-llc/e8b32c0e-75d3-4a19-b7a3-25e180662cb7

> FDA 483 for Cumberland Biotherapeutics LLC on June 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cumberland Biotherapeutics LLC
- Inspection Date: 2024-06-27
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Cumberland Biotherapeutics LLC, a medical device manufacturer in Sewanee, TN, was inspected by the FDA from June 25-27, 2024. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established quality objectives, inadequate supplier control procedures, and the absence of a corrective and preventive action system. These findings indicate a fundamental breakdown in the firm's quality management practices.

## Related Officers

- [Benjamin E. Bowen](https://www.keypedia.com/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.keypedia.com/companies/cumberland-biotherapeutics-llc/d2e12008-f5a7-46ab-ad12-f0e0baa8c870

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