Center for Reproductive Medicine & Robotic Surgery LLCOctober 4, 2019

FDA 483 - Center for Reproductive Medicine & Robotic Surgery LLC - October 04, 2019

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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.

Company: Center for Reproductive Medicine & Robotic Surgery LLC
Inspection Date: October 4, 2019
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West II
Person: Kathleen B. Swat (Supervisory)

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ID · ff549e36-8eec-49ab-8430-1f4ae1cdb7fa