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

Source: https://www.keypedia.com/records/483/center-for-reproductive-medicine-robotic-surgery-llc/ff549e36-8eec-49ab-8430-1f4ae1cdb7fa

> FDA 483 for Center for Reproductive Medicine & Robotic Surgery LLC on October 04, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Center for Reproductive Medicine & Robotic Surgery LLC
- Inspection Date: 2019-10-04
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2024-03-11](https://www.keypedia.com/records/483/center-for-reproductive-medicine-robotic-surgery-llc/18569d17-62d2-4bbb-b299-57cbcca9b4e3)

## Related Officers

- [Supervisory](https://www.keypedia.com/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)

Company: https://www.keypedia.com/companies/center-for-reproductive-medicine-robotic-surgery-llc/4ad8cbb8-9102-4345-a1af-362a265bf830

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8