# FDA 483 - C.A.R.E. Fertility - October 26, 2023

Source: https://www.keypedia.com/records/483/care-fertility/0ce9e0c6-f209-4f12-a74e-4bd7e56297c8

> FDA 483 for C.A.R.E. Fertility on October 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C.A.R.E. Fertility
- Inspection Date: 2023-10-26
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: C.A.R.E. Fertility in Glendale, CA, was cited for significant deficiencies in its human cells, tissues, and cellular and tissue-based products (HCT/P) program. The inspection revealed failures in donor screening for communicable diseases, inadequate donor eligibility procedures, improper quarantine and labeling of HCT/Ps, and insufficient record retention. These issues indicate a lack of control over critical processes for ensuring HCT/P safety.

## Related Documents

- [483 - 2019-04-11](https://www.keypedia.com/records/483/care-fertility/1472a632-b7db-4565-80bc-9b7c5478fdec)

## Related Officers

- [Michael Blaine](https://www.keypedia.com/people/michael-blaine/292e4de2-e1b4-4057-b551-ebd2b195e109)
- [Celeta S. Coves](https://www.keypedia.com/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

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