# FDA 483 - C.A.R.E. Fertility - April 11, 2019

Source: https://www.keypedia.com/records/483/care-fertility/1472a632-b7db-4565-80bc-9b7c5478fdec

> FDA 483 for C.A.R.E. Fertility on April 11, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: C.A.R.E. Fertility
- Inspection Date: 2019-04-11
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of C.A.R.E. Fertility in Glendale, CA, revealed a significant concern regarding donor eligibility. The firm failed to determine donors ineligible despite evidence of risk factors or clinical signs of communicable disease agents. This included accepting donors with Zika virus exposure risks and those who had not completed required medical history interviews or physical assessments.

## Related Documents

- [483 - 2023-10-26](https://www.keypedia.com/records/483/care-fertility/0ce9e0c6-f209-4f12-a74e-4bd7e56297c8)

## Related Officers

- [Erma Zaimova](https://www.keypedia.com/people/erma-zaimova/87da23ad-48bb-4096-9d8a-e8511c6b5c98)

Company: https://www.keypedia.com/companies/care-fertility/ab54967c-f864-4819-966b-d22401b398df

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