483
Reproductive Medicine & Infertility AssociatesReproductive Medicine & Infertility Associates – FDA 483, Jul 31, 2026
Record Details
Reproductive Medicine & Infertility Associates in Augusta, GA, received a Form 483 for deficiencies in donor screening and testing procedures. The firm failed to adequately screen donors for communicable disease agents, including missing required physical examinations and medical history. Additionally, the company's standard operating procedures for HCT/P donor testing did not reference all required FDA tests.
- Inspection date
- July 31, 2026
- Product type
- biologics
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ID · d716d05d-a45e-4cfa-ae4e-a25cd6baf45e
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