# FDA 483 - Stony Brook Community Medical PC - Island Fertility - July 30, 2021

Source: https://www.globalkeysolutions.net/records/483/stony-brook-community-medical-pc-island-fertility/8b8a4287-7a16-42d8-af8e-44495f3bf16e

> FDA 483 for Stony Brook Community Medical PC - Island Fertility on July 30, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stony Brook Community Medical PC - Island Fertility
- Inspection Date: 2021-07-30
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Stony Brook Community Medical PC - Island Fertility, a reproductive human tissue establishment, revealed significant deficiencies in donor eligibility determination. The firm failed to properly screen and test HCT/P donors for communicable diseases and infectious agents, and its procedures for donor eligibility were inadequate. Additionally, HCT/Ps that did not meet eligibility requirements were transferred to other facilities without proper warning labels.

## Related Documents

- [483 - 2022-07-13](https://www.globalkeysolutions.net/records/483/stony-brook-community-medical-pc-island-fertility/bbc42ca6-d7d9-4e6f-b63f-0f5e63046413)
- [483 - 2024-05-28](https://www.globalkeysolutions.net/records/483/stony-brook-community-medical-pc-island-fertility/7f0f8dde-2621-414d-938c-c01e21fcf267)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/stony-brook-community-medical-pc-island-fertility/6fb097c7-beb2-46f4-aaac-dd58bfabd7d1

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