# FDA 483 - University Fertility Center - August 10, 2021

Source: https://www.keypedia.com/records/483/university-fertility-center/c3652784-b606-4e76-b8f4-88c3ab020ccd

> FDA 483 for University Fertility Center on August 10, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Fertility Center
- Inspection Date: 2021-08-10
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of University Fertility Laboratory, Inc. in Torrance, CA, revealed two repeat observations concerning the handling and labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps until donor eligibility was determined and did not properly label HCT/Ps that did not meet donor eligibility requirements with appropriate warning statements. These deficiencies indicate a serious lack of compliance with regulatory standards.

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## Related Officers

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

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

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