# FDA 483 - Neway Medical, P.C. - December 20, 2024

Source: https://www.keypedia.com/records/483/neway-medical-pc/0000f559-49ff-42f4-b5f3-25b8bcf54a46

> FDA 483 for Neway Medical, P.C. on December 20, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neway Medical, P.C.
- Inspection Date: 2024-12-20
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Neway Medical, P.C. in New York, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in donor eligibility screening, testing, record-keeping, and associated procedures. These issues indicate a lack of robust controls to ensure the safety and eligibility of HCT/P donors and tissues.

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- [483 - 2022-11-08](https://www.keypedia.com/records/483/neway-medical-pc/9dd635c0-5859-4603-a676-d51bab5d47c9)
- [483 - 2024-12-20](https://www.keypedia.com/records/483/neway-medical-pc/054fcd76-e2b7-44ee-b6bb-2706897ee686)

## Related Officers

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

Company: https://www.keypedia.com/companies/neway-medical-pc/bcf33dee-83e2-4b53-8d35-25c77ea268d3

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