# FDA 483 - University Fertility Center - February 04, 2019

Source: https://www.globalkeysolutions.net/records/483/university-fertility-center/7f1e4db6-d4e1-4ada-b302-7ae0b8e0441d

> FDA 483 for University Fertility Center on February 04, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Fertility Center
- Inspection Date: 2019-02-04
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: University Fertility Center in Torrance, CA, received a Form 483 following an inspection related to human reproductive tissue. The inspection revealed significant deficiencies in donor screening and testing procedures for communicable disease agents, including inadequate questionnaires and a lack of required West Nile Virus testing for several oocyte donors. Additionally, the firm's procedures for determining donor eligibility were not adequately defined or implemented.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)

Company: https://www.globalkeysolutions.net/companies/university-fertility-center/0bbecf8a-0ac3-489d-a50b-29a88b76e1c2

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6