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

Source: https://www.keypedia.com/records/483/neway-medical-pc/054fcd76-e2b7-44ee-b6bb-2706897ee686

> 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: New York District Office
- 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 determination, screening procedures, and record accuracy. These issues indicate a failure to ensure the safety and suitability of donated HCT/Ps.

## Related Documents

- [483 - 2019-03-27](https://www.keypedia.com/records/483/neway-medical-pc/ff1b52e5-c93f-4f11-bc39-b815d0d6842b)
- [483 - 2022-11-08](https://www.keypedia.com/records/483/neway-medical-pc/9dd635c0-5859-4603-a676-d51bab5d47c9)

## 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/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d