483
Center for Reproductive Medicine & Robotic Surgery LLCCenter for Reproductive Medicine & Robotic Surgery LLC – FDA 483, Mar 11, 2024
Record Details
The Center for Reproductive Medicine & Robotic Surgery LLC in Saint Louis, MO, received a Form 483 for two significant observations during an FDA inspection. The firm failed to adequately screen oocyte donors for numerous communicable disease risk factors, including Zika virus, using an insufficient medical history questionnaire. Additionally, the facility lacked a standard operating procedure for the release of HCT/Ps from donors who test reactive for cytomegalovirus.
- Inspection date
- March 11, 2024
- Product type
- biologics
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ID · 18569d17-62d2-4bbb-b299-57cbcca9b4e3
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