# FDA 483 - Neway Medical, P.C. - March 27, 2019

Source: https://www.globalkeysolutions.net/records/483/neway-medical-pc/ff1b52e5-c93f-4f11-bc39-b815d0d6842b

> FDA 483 for Neway Medical, P.C. on March 27, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neway Medical, P.C.
- Inspection Date: 2019-03-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: American Fertility Services, P.C. in New York, NY, a reproductive HCT/P establishment, was cited for deficiencies in its donor screening processes. The firm failed to adequately screen oocyte donors for communicable disease risk factors, including Zika and West Nile Viruses. Additionally, procedures for determining donor eligibility were found to be outdated and not properly maintained or revised.

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## Related Officers

- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

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