# FDA 483 - Alabama Center for Reproductive Medicine - September 15, 2025

Source: https://www.keypedia.com/records/483/alabama-center-for-reproductive-medicine/63385072-8a3c-466f-a4be-5ce203223cc4

> FDA 483 for Alabama Center for Reproductive Medicine on September 15, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alabama Center for Reproductive Medicine
- Inspection Date: 2025-09-15
- Product Type: biologics
- Office Name: Kansas City District Office
- Summary: From September 11 to September 15, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Alabama Center for Reproductive Medicine in Birmingham, Alabama. The inspection focused on the facility"s processes for handling reproductive tissues and revealed several deficiencies in donor eligibility protocols. Specifically, the center failed to establish and maintain comprehensive written procedures for screening donors of human cells and tissues. Key observations included a lack of detailed instructions for performing physical examinations to identify signs of communicable diseases and the absence of clear criteria for determining donor eligibility based on exam results. Furthermore, the facility lacked standardized protocols for evaluating donor history questionnaires, including guidance on how to conduct follow-up inquiries for specific health responses. The inspector also noted that the center did not have established procedures for embryo donations, missing critical requirements for documentation such as donor eligibility statements and mandatory health warning labels. These observations were made under the regulatory framework of 21 CFR Part 1271. While the FDA has not yet made a final determination on the facility"s compliance status, the Medical Director, Dr. Cecil A. Long, is expected to address these findings. The center must implement corrective actions to ensure all screening and donation procedures meet federal safety standards and provide a formal response to the FDA outlining these improvements.

## Related Documents

- [483 - 2025-09-15](https://www.keypedia.com/records/483/alabama-center-for-reproductive-medicine/7a7a8850-b429-4b7a-be22-8bf59c7bf9be)

## Related Officers

- [Juanelma H. Palmer](https://www.keypedia.com/people/juanelma-h-palmer/db3e79b5-d2d4-46d8-a075-4674dbc8c3d0)

Company: https://www.keypedia.com/companies/alabama-center-for-reproductive-medicine/5e7c5db1-983f-455a-9ea7-988d1dbd3190

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79