# FDA 483 - Foulk & Whitten Nevada Center For Reproductive Medicine - March 28, 2019

Source: https://www.keypedia.com/records/483/foulk-whitten-nevada-center-for-reproductive-medicine/e3a45cfa-43cc-4aed-9ccc-391c0ebc9a5b

> FDA 483 for Foulk & Whitten Nevada Center For Reproductive Medicine on March 28, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Foulk & Whitten Nevada Center For Reproductive Medicine
- Inspection Date: 2019-03-28
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Nevada Center For Reproductive Medicine, a human reproductive tissue establishment in Reno, NV, revealed significant deficiencies in donor screening practices. The firm failed to adequately screen donors for various communicable disease agents and lacked established procedures for determining donor eligibility and documenting ineligibility reasons for HCT/Ps. These findings indicate serious concerns regarding the safety and quality of donor tissues.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/foulk-whitten-nevada-center-for-reproductive-medicine/f8f79544-940c-4a60-91cf-8dd23cd883e8

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