483
Manhattan Reproductive Medicine, PCFDA 483 - Manhattan Reproductive Medicine, PC - June 29, 2022
Record Details
Manhattan Reproductive Medicine, PC, a human reproductive tissue establishment, was cited for deficiencies during an FDA inspection. The firm failed to adequately screen oocyte donors for communicable disease risk factors, specifically Zika Virus, due to an incomplete questionnaire. Additionally, the firm lacked established written procedures for utilizing its electronic donor screening system.
Open in Dashboard
ID · db28ec06-ca81-490b-b6c5-214c9d25750d