Incinta Fertility Center, LLCMarch 3, 2022

FDA 483 - Incinta Fertility Center, LLC - March 03, 2022

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Record Details

Incinta Fertility Center, L.L.C. in Torrance, CA, a human reproductive tissue establishment, was inspected by the FDA. The inspection revealed deficiencies in donor screening processes, specifically regarding the evaluation of communicable disease risks for oocyte and semen donors. The firm failed to adequately screen for ZIKA Virus and lacked comprehensive physical examination questions for female donors.

Company: Incinta Fertility Center, LLC
Inspection Date: March 3, 2022
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Yvonne C. Wilkes (investigator)

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