Alabama Center for Reproductive Medicine – FDA 483, Sep 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.
- Inspection date
- September 15, 2025
- Product type
- biologics
- Person
ID · 7a7a8850-b429-4b7a-be22-8bf59c7bf9be
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