# FDA 483 - Yale Center For Reproductive Medicine & Infertility - September 23, 2020

Source: https://www.globalkeysolutions.net/records/483/yale-center-for-reproductive-medicine-infertility/1ab3896c-6d8b-4c52-88b4-f646311ee536

> FDA 483 for Yale Center For Reproductive Medicine & Infertility on September 23, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yale Center For Reproductive Medicine & Infertility
- Inspection Date: 2020-09-23
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Yale Center For Reproductive Medicine & Infertility in Orange, CT, revealed a significant deficiency in donor screening practices. The firm failed to test four anonymous oocyte donors for West Nile Virus between June and October 2018, despite determining them eligible to donate and subsequently retrieving and fertilizing their oocytes. This lapse in communicable disease agent testing raises concerns about the safety of human reproductive tissue.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/yale-center-for-reproductive-medicine-infertility/f8b19a6b-b4a1-451b-8207-13a0b06d369b

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94