# FDA 483 - Neway Medical, P.C. - November 08, 2022

Source: https://www.globalkeysolutions.net/records/483/neway-medical-pc/9dd635c0-5859-4603-a676-d51bab5d47c9

> FDA 483 for Neway Medical, P.C. on November 08, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Neway Medical, P.C.
- Inspection Date: 2022-11-08
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Neway Medical, P.C. in New York was inspected regarding its human reproductive tissue (oocytes & semen) operations. The inspection revealed significant deficiencies in donor screening for communicable diseases, inadequate documentation, and non-compliant standard operating procedures. These issues indicate a systemic failure to ensure donor eligibility and proper record-keeping for HCT/Ps.

## Related Documents

- [483 - 2019-03-27](https://www.globalkeysolutions.net/records/483/neway-medical-pc/ff1b52e5-c93f-4f11-bc39-b815d0d6842b)
- [483 - 2024-12-20](https://www.globalkeysolutions.net/records/483/neway-medical-pc/054fcd76-e2b7-44ee-b6bb-2706897ee686)

## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)

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

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