# FDA 483 - Unity Fertility Center, LLC - September 02, 2021

Source: https://www.globalkeysolutions.net/records/483/unity-fertility-center-llc/3da00b5c-693d-4633-835f-c6a197d1962d

> FDA 483 for Unity Fertility Center, LLC on September 02, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unity Fertility Center, LLC
- Inspection Date: 2021-09-02
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Unity Fertility Center, LLC in Pasadena, CA, a human reproductive tissue establishment, revealed significant deficiencies in donor eligibility determination and procedural controls. The firm failed to properly determine and document donor eligibility based on testing results, and lacked established procedures for screening and testing HCT/P donors, including those for directed semen donors. Furthermore, the facility did not have a written procedure for releasing reproductive tissue from donors who tested reactive for cytomegalovirus (CMV).

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ka-l-wong/e624263d-e2c0-4b80-b5d9-ea84e29baa6b)

Company: https://www.globalkeysolutions.net/companies/unity-fertility-center-llc/98e87499-be8c-4565-b6e7-8ee0f307d29d

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