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

The FDA inspected Alabama Center for Reproductive Medicine in Birmingham, AL, and issued a Form 483. The inspection revealed a significant lack of established and maintained procedures for screening and determining the eligibility of HCT/P donors. This included deficiencies in physical exam protocols, donor eligibility criteria, and embryo donation procedures, indicating a failure to ensure proper donor screening processes for reproductive tissues.