# FDA 483 - NYC In Vitro Fertilization, P.C. - August 22, 2022

Source: https://www.globalkeysolutions.net/records/483/nyc-in-vitro-fertilization-pc/e4d87de4-c9ca-4cc1-9051-7ebb2c13b48f

> FDA 483 for NYC In Vitro Fertilization, P.C. on August 22, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NYC In Vitro Fertilization, P.C.
- Inspection Date: 2022-08-22
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: NYC In Vitro Fertilization, P.C. in New York, NY, a human reproductive tissue establishment, was cited for deficiencies in its donor screening practices. The inspection revealed that the firm failed to adequately screen anonymous oocyte donors for various communicable disease risk factors. Additionally, the firm did not establish and maintain proper procedures for determining the eligibility of HCT/P donors, indicating a lack of robust quality controls.

## Related Officers

- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

Company: https://www.globalkeysolutions.net/companies/nyc-in-vitro-fertilization-pc/8538e1b4-3e82-4d37-84f8-37c652aef901

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961