# FDA 483 - Incinta Fertility Center, LLC - February 24, 2025

Source: https://www.keypedia.com/records/483/incinta-fertility-center-llc/2bf46379-d015-453c-bfe8-2d8ed284fd53

> FDA 483 for Incinta Fertility Center, LLC on February 24, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Incinta Fertility Center, LLC
- Inspection Date: 2025-02-24
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: Incinta Fertility Center, LLC in Torrance, CA, was cited for significant deficiencies in its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed failures in labeling HCT/Ps from ineligible donors, inadequate screening procedures for communicable disease risks, and improper maintenance of donor records that included personally identifiable information for anonymous donors. These issues indicate a lack of control over critical aspects of donor eligibility and HCT/P management.

## Related Documents

- [483 - 2022-03-03](https://www.keypedia.com/records/483/incinta-fertility-center-llc/caf8402f-2cb4-4bb7-a0bb-e35d1cfb6f48)
- [483 - 2023-05-02](https://www.keypedia.com/records/483/incinta-fertility-center-llc/3ec52491-415c-4614-88d7-a98cb49d1b21)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b