# FDA 483 - Envita Fertility Center - October 06, 2023

Source: https://www.globalkeysolutions.net/records/483/envita-fertility-center/185a24a5-59c0-4430-bf9a-9dfbb8da268d

> FDA 483 for Envita Fertility Center on October 06, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Envita Fertility Center
- Inspection Date: 2023-10-06
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Envita Fertility Center in Laguna Hills, CA, a reproductive fertility center, was cited for two observations during an FDA inspection. The firm was found to have included identifying donor information in HCT/P records and to have implemented donor eligibility procedures without proper review and approval by a responsible person. These issues indicate deficiencies in donor privacy and procedural control.

## Related Documents

- [483 - 2023-10-06](https://www.globalkeysolutions.net/records/483/envita-fertility-center/d455e325-c173-4e23-a546-8142d1001dca)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/envita-fertility-center/af36f8a6-5d1d-49e5-9461-a7e619cb4874

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