# FDA 483 - Island Reproductive Services - January 26, 2023

Source: https://www.globalkeysolutions.net/records/483/island-reproductive-services/4f9ff68c-d093-4b0b-af2b-89515537a48f

> FDA 483 for Island Reproductive Services on January 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Island Reproductive Services
- Inspection Date: 2023-01-26
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Island Reproductive Services in Staten Island, NY, was cited for significant deficiencies in its human reproductive tissue program, specifically concerning oocyte donor screening and eligibility. The firm failed to adequately screen donors for communicable diseases and risk factors, prematurely determined donor eligibility before test results were available, and maintained inadequate standard operating procedures and inaccurate donor eligibility records. These issues indicate a systemic failure to ensure donor safety and compliance with regulatory requirements.

## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)

Company: https://www.globalkeysolutions.net/companies/island-reproductive-services/40b62c93-8179-4fec-bf39-0097a202d457

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