483
Neway Medical, P.C.FDA 483 - Neway Medical, P.C. - November 08, 2022
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Record Details
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.
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ID · 9dd635c0-5859-4603-a676-d51bab5d47c9