# FDA 483 - RMA Long Island IVF - March 01, 2022

Source: https://www.keypedia.com/records/483/rma-long-island-ivf/28eb2e2c-2d3c-4993-bb38-0b030aecf5e6

> FDA 483 for RMA Long Island IVF on March 01, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RMA Long Island IVF
- Inspection Date: 2022-03-01
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of RMA Long Island IVF in Melville, NY, revealed deficiencies in determining HCT/P donor eligibility. The firm failed to adequately screen oocyte donors for Zika virus risk factors and accepted donations from a donor with an incomplete risk factor questionnaire. These issues indicate a failure to ensure donor suitability prior to donation.

## Related Documents

- [483 - 2024-02-09](https://www.keypedia.com/records/483/rma-long-island-ivf/cd0700b1-a825-46e0-bd12-ad43b5937daa)

## Related Officers

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

Company: https://www.keypedia.com/companies/rma-long-island-ivf/cd54c3fa-c54b-41c1-a844-8eafdb85b4f3

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