Neway Medical, P.C.December 20, 2024

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

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Record Details

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.

Company: Neway Medical, P.C.
Inspection Date: December 20, 2024
Product Type: Biologics
Office: New York District Office
Person: Irina Gaberman (Investigator)

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ID · 054fcd76-e2b7-44ee-b6bb-2706897ee686