# FDA 483 - Incinta Fertility Center, LLC - May 02, 2023

Source: https://www.keypedia.com/records/483/incinta-fertility-center-llc/3ec52491-415c-4614-88d7-a98cb49d1b21

> FDA 483 for Incinta Fertility Center, LLC on May 02, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Incinta Fertility Center, LLC
- Inspection Date: 2023-05-02
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Incinta Fertility Center, LLC in Torrance, CA, was cited for deficiencies in its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps from donors not adequately screened for Zika Virus and did not apply appropriate warning labels to HCT/Ps from ineligible donors. Additionally, the company lacked established and maintained procedures for testing, screening, and determining the eligibility of HCT/P donors for infectious diseases like HBV NAT, Zika virus, and WNV.

## Related Documents

- [483 - 2022-03-03](https://www.keypedia.com/records/483/incinta-fertility-center-llc/caf8402f-2cb4-4bb7-a0bb-e35d1cfb6f48)
- [483 - 2025-02-24](https://www.keypedia.com/records/483/incinta-fertility-center-llc/2bf46379-d015-453c-bfe8-2d8ed284fd53)

## Related Officers

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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