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

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.