483
Center for Reproductive Medicine & Robotic Surgery LLCCenter for Reproductive Medicine & Robotic Surgery LLC – FDA 483, Oct 4, 2019
Record Details
An FDA inspection of Center for Reproductive Medicine & Robotic Surgery LLC in Saint Louis, MO, revealed significant deficiencies in their reproductive tissue operations. The firm failed to adequately test oocyte donors for communicable diseases like West Nile Virus and Zika Virus. Additionally, the facility did not maintain proper documentation for donor eligibility determinations.
- Inspection date
- October 4, 2019
- Product type
- biologics
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ID · ff549e36-8eec-49ab-8430-1f4ae1cdb7fa
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