# Stony Brook Community Medical PC - Island Fertility – FDA 483, May 28, 2024

Source: https://www.keypedia.com/records/483/stony-brook-community-medical-pc-island-fertility/7f0f8dde-2621-414d-938c-c01e21fcf267

> FDA 483 for Stony Brook Community Medical PC - Island Fertility on May 28, 2024. 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: 2024-05-28
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Stony Brook Community Medical PC - Island Fertility, a reproductive human tissue establishment, was cited for significant deficiencies in donor eligibility determination, screening, testing, and labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed instances where donors with positive communicable disease tests or incomplete screening were deemed eligible, and HCT/Ps from ineligible donors were not properly labeled with biohazard warnings. Additionally, the firm's standard operating procedures for donor screening lacked clear criteria, potentially allowing ineligible tissues to proceed without proper evaluation.

## Related Documents

- [483 - 2022-07-13](https://www.keypedia.com/records/483/stony-brook-community-medical-pc-island-fertility/bbc42ca6-d7d9-4e6f-b63f-0f5e63046413) — date: July 13, 2022
- [483 - 2021-07-30](https://www.keypedia.com/records/483/stony-brook-community-medical-pc-island-fertility/8b8a4287-7a16-42d8-af8e-44495f3bf16e) — date: July 30, 2021

## Related Officers

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

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

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