# FDA 483 - New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C - March 28, 2025

Source: https://www.globalkeysolutions.net/records/483/new-york-reproductive-wellness-medicine-pc-dba-oma-labs-long-island-llc/716346de-d3cb-4caa-baf5-184f337d1ab8

> FDA 483 for New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C on March 28, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C
- Inspection Date: 2025-03-28
- Product Type: other
- Office Name: New York District Office
- Summary: An FDA inspection of New York Reproductive Wellness Medicine, P.C. in Syosset, NY, revealed a significant violation regarding the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to prominently label HCT/Ps with appropriate warning statements when donor eligibility requirements were not met, including instances involving a donor with Creutzfeldt Jacob Disease (CJD) risk and reproductive tissues shipped without proper communicable disease risk warnings. This lapse indicates a serious concern for recipient safety and regulatory compliance.

## Related Documents

- [483 - 2023-04-07](https://www.globalkeysolutions.net/records/483/new-york-reproductive-wellness-medicine-pc-dba-oma-labs-long-island-llc/38258d05-6225-4389-9dc1-8eca46603a9e)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/new-york-reproductive-wellness-medicine-pc-dba-oma-labs-long-island-llc/4dae2c87-06ba-4f3c-a349-b8541bd75bec

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d