# FDA 483 - Tennessee Reproductive Medicine - August 04, 2022

Source: https://www.keypedia.com/records/483/tennessee-reproductive-medicine/d3efb69d-b022-4a54-8e70-7b78a2575ac0

> FDA 483 for Tennessee Reproductive Medicine on August 04, 2022. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Tennessee Reproductive Medicine
- Inspection Date: 2022-08-04
- Product Type: other
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Tennessee Reproductive Medicine in Chattanooga, TN, revealed significant deficiencies in their donor eligibility determination processes for reproductive tissues. The firm lacked adequate procedures for screening donors against various health risks and travel histories, and released HCT/Ps without complete testing or proper warning labels. These findings indicate a failure to ensure compliance with donor eligibility requirements and appropriate product handling.

## Related Officers

- [Johnathan M Crayton](https://www.keypedia.com/people/johnathan-m-crayton/84dace1c-dfbe-4dcc-a9f2-f12bdd3e0c3a)

Company: https://www.keypedia.com/companies/tennessee-reproductive-medicine/27ca45aa-cb16-495d-ab07-c1464d6e5292

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