483
Midwest Fertility SpecialistsMidwest Fertility Specialists – FDA 483, Nov 25, 2024
Record Details
Midwest Fertility Specialists, a reproductive establishment in Carmel, IN, was cited with two observations during an FDA inspection. The firm failed to adequately screen directed semen donors for relevant communicable disease agents and diseases (RCDADs) due to incomplete medical history and physical assessment forms. Additionally, the firm lacked established and maintained procedures for screening HCT/P donors, specifically regarding CJD/vCJD risk factors.
- Office
- Detroit District Office
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ID · f14538ef-5424-4b6c-afa1-f4b5218cc117
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