# FDA 483 - New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C - April 07, 2023

Source: https://www.globalkeysolutions.net/records/483/new-york-reproductive-wellness-medicine-pc-dba-oma-labs-long-island-llc/38258d05-6225-4389-9dc1-8eca46603a9e

> FDA 483 for New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C on April 07, 2023. Product: biologics. 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: 2023-04-07
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New York Reproductive Wellness Medicine, P.C. d.b.a. Oma Labs Long Island, L.L.C in Syosset, NY, identified two significant observations. The firm failed to ensure HCT/P donor eligibility was determined based on complete screening and testing results, specifically for an anonymous oocyte donor. Additionally, accompanying records for anonymous HCT/P donors contained personal identifying information, which is a concern for donor anonymity.

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## 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/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961