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

Source: https://www.keypedia.com/records/483/incinta-fertility-center-llc/caf8402f-2cb4-4bb7-a0bb-e35d1cfb6f48

> FDA 483 for Incinta Fertility Center, LLC on March 03, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Incinta Fertility Center, LLC
- Inspection Date: 2022-03-03
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

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## Related Officers

- [investigator](https://www.keypedia.com/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)

Company: https://www.keypedia.com/companies/incinta-fertility-center-llc/36046ca3-cebe-4278-bd85-191c0df0715e

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6