# FDA 483 - Montefiore's Institute for Reproductive Medicine and Health - May 03, 2019

Source: https://www.globalkeysolutions.net/records/483/montefiores-institute-for-reproductive-medicine-and-health/8ec76984-a358-47fb-a632-f8ae5e62b858

> FDA 483 for Montefiore's Institute for Reproductive Medicine and Health on May 03, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Montefiore's Institute for Reproductive Medicine and Health
- Inspection Date: 2019-05-03
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Montefiore's Institute for Reproductive Medicine and Health in Hartsdale, NY, revealed two significant observations related to human reproductive tissue. The firm failed to properly determine and document the eligibility of oocyte donors, specifically by not testing for West Nile Virus. Additionally, the firm's standard operating procedures for egg donor screening were not revised to include seasonal West Nile Virus testing.

## Related Documents

- [483 - 2021-08-16](https://www.globalkeysolutions.net/records/483/montefiores-institute-for-reproductive-medicine-and-health/7078f988-597f-421d-9030-99f50fcd2e0b)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.globalkeysolutions.net/companies/montefiores-institute-for-reproductive-medicine-and-health/c2c381cf-43a5-4aab-8eff-97119d58d36b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961