# FDA 483 - Center For Advanced Reproductive Medicine & Fertility - July 19, 2019

Source: https://www.globalkeysolutions.net/records/483/center-for-advanced-reproductive-medicine-fertility/c099ac92-964f-4be2-9cce-f640b9047b6a

> FDA 483 for Center For Advanced Reproductive Medicine & Fertility on July 19, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Center For Advanced Reproductive Medicine & Fertility
- Inspection Date: 2019-07-19
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: The FDA inspected Center For Advanced Reproductive Medicine & Fertility in Edison, NJ, a human reproductive tissue establishment. The inspection revealed that the firm failed to test multiple anonymous oocyte donors for West Nile Virus, a relevant communicable disease agent, before determining their eligibility. Additionally, the firm's standard operating procedures were found to be deficient as they did not include West Nile Virus in the list of required infectious disease tests for gamete donors.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jennifer-l-custodio/489a8b9c-ab8d-4d37-b89c-6086889e825c)

Company: https://www.globalkeysolutions.net/companies/center-for-advanced-reproductive-medicine-fertility/620d386d-bc03-4273-8d90-037513da7e5d

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248