# FDA 483 - RMA Long Island IVF - February 09, 2024

Source: https://www.keypedia.com/records/483/rma-long-island-ivf/cd0700b1-a825-46e0-bd12-ad43b5937daa

> FDA 483 for RMA Long Island IVF on February 09, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: RMA Long Island IVF
- Inspection Date: 2024-02-09
- 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, a reproductive human tissue establishment, identified significant issues related to donor eligibility determination and record-keeping. The firm failed to properly determine and document HCT/P donor eligibility, particularly for directed semen donors whose partners tested positive for communicable diseases. Additionally, the facility lacked established procedures for screening and determining donor eligibility and maintained inaccurate, illegible, and altered donor eligibility records.

## Related Documents

- [483 - 2022-03-01](https://www.keypedia.com/records/483/rma-long-island-ivf/28eb2e2c-2d3c-4993-bb38-0b030aecf5e6)

## 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