# FDA 483 - Center for Reproductive Medicine & Robotic Surgery LLC - March 11, 2024

Source: https://www.keypedia.com/records/483/center-for-reproductive-medicine-robotic-surgery-llc/18569d17-62d2-4bbb-b299-57cbcca9b4e3

> FDA 483 for Center for Reproductive Medicine & Robotic Surgery LLC on March 11, 2024. 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: 2024-03-11
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2019-10-04](https://www.keypedia.com/records/483/center-for-reproductive-medicine-robotic-surgery-llc/ff549e36-8eec-49ab-8430-1f4ae1cdb7fa)

## Related Officers

- [Esther A. Ofori](https://www.keypedia.com/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)

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