# FDA 483 - HRC Fertility - May 24, 2023

Source: https://www.keypedia.com/records/483/hrc-fertility/376b2bcb-a19f-4ad0-8e0a-de1867673575

> FDA 483 for HRC Fertility on May 24, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HRC Fertility
- Inspection Date: 2023-05-24
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of HRC Fertility, a human tissue reproductive establishment in Carlsbad, CA, identified one observation. The firm failed to adequately screen donors for communicable disease risk factors, specifically regarding West Nile Virus (WNV) infection. This was due to a donor screening questionnaire that did not solicit information about recent WNV NAT test results.

## Related Officers

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

Company: https://www.keypedia.com/companies/hrc-fertility/b4bfa8a3-bf78-45b9-93e5-c3aea1d89b0d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b