# FDA 483 - Greenwich Fertility & Ivf Center, P.c. - March 11, 2022

Source: https://www.keypedia.com/records/483/greenwich-fertility-ivf-center-pc/ccb2c203-5fa4-4c31-bf86-9fa7813bb1da

> FDA 483 for Greenwich Fertility & Ivf Center, P.c. on March 11, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greenwich Fertility & Ivf Center, P.c.
- Inspection Date: 2022-03-11
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Greenwich Fertility & Ivf Center, P.c. identified significant issues related to human reproductive tissue processing. Observations included inadequate screening of egg donors for communicable diseases, specifically Zika Virus, and failures in maintaining donor anonymity. Additionally, the facility's records for HCT/Ps did not properly document donor-eligibility determinations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.keypedia.com/companies/greenwich-fertility-ivf-center-pc/d30e7f74-a494-4f6f-9087-a9e621c0d8b4

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94
