# FDA 483 - Center for Reproductive Health Fertility Laboratory of Nashville - June 30, 2022

Source: https://www.keypedia.com/records/483/center-for-reproductive-health-fertility-laboratory-of-nashville/8bc966f7-8bbe-4063-89b9-fe425f1c0ffd

> FDA 483 for Center for Reproductive Health Fertility Laboratory of Nashville on June 30, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Center for Reproductive Health Fertility Laboratory of Nashville
- Inspection Date: 2022-06-30
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: The FDA issued a Form 483 to Center for Reproductive Health Fertility Laboratory of Nashville following an inspection that identified five significant observations. The firm failed to adequately document HCT/P donor eligibility, maintain complete summary records for donor determinations, and ensure written procedures were available and staff trained. These issues highlight deficiencies in the firm's control over critical aspects of human cell and tissue product processing.

## Related Documents

- [483 - 2019-03-01](https://www.keypedia.com/records/483/center-for-reproductive-health-fertility-laboratory-of-nashville/96a5824a-e890-4a38-9b25-cda6a00435a1)
- [483 - 2024-02-23](https://www.keypedia.com/records/483/center-for-reproductive-health-fertility-laboratory-of-nashville/9c8c3f83-a139-45ea-afa7-397be9916b0e)

## Related Officers

- [Christopher J. Adams](https://www.keypedia.com/people/christopher-j-adams/f7010846-7fd1-4ee8-901a-1015656fea0a)

Company: https://www.keypedia.com/companies/center-for-reproductive-health-fertility-laboratory-of-nashville/7a172a0b-9407-4b4f-ad0f-2cf509b75adb

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