# FDA 483 - Montefiore's Institute for Reproductive Medicine and Health - August 16, 2021

Source: https://www.globalkeysolutions.net/records/483/montefiores-institute-for-reproductive-medicine-and-health/7078f988-597f-421d-9030-99f50fcd2e0b

> FDA 483 for Montefiore's Institute for Reproductive Medicine and Health on August 16, 2021. 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: 2021-08-16
- 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 significant deficiencies in donor screening procedures for communicable diseases. The firm failed to adequately screen oocyte and semen donors for Zika virus due to incomplete medical history forms. Additionally, the facility's standard operating procedures and forms for Zika virus donor eligibility were found to be incorrect and not adequately reviewed or revised.

## Related Documents

- [483 - 2019-05-03](https://www.globalkeysolutions.net/records/483/montefiores-institute-for-reproductive-medicine-and-health/8ec76984-a358-47fb-a632-f8ae5e62b858)

## 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