# FDA 483 - San Diego Fertility Center, Medical Group Inc - May 26, 2023

Source: https://www.globalkeysolutions.net/records/483/san-diego-fertility-center-medical-group-inc/8d24f032-011a-4f3d-be87-2f4589ab198c

> FDA 483 for San Diego Fertility Center, Medical Group Inc on May 26, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: San Diego Fertility Center, Medical Group Inc
- Inspection Date: 2023-05-26
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of San Diego Fertility Center, Medical Group, Inc, a human reproductive tissue establishment, identified a significant deficiency in donor screening practices. The firm failed to adequately screen donors for communicable disease agents and diseases. This included missing critical risk factors for West Nile Virus, HIV group O, and xenotransplantation exposure on their donor medical history questionnaire.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/paul-m-chefor/96bea4a8-b1ee-4870-ae8b-24794c67da21)

Company: https://www.globalkeysolutions.net/companies/san-diego-fertility-center-medical-group-inc/38691b9e-30cd-4701-9dff-70b44c30867f

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