# FDA 483 - Foulk Nevada Fertility Center, PC - February 08, 2019

Source: https://www.keypedia.com/records/483/foulk-nevada-fertility-center-pc/61f160c6-2622-4505-ab67-6ae4395440d6

> FDA 483 for Foulk Nevada Fertility Center, PC on February 08, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Foulk Nevada Fertility Center, PC
- Inspection Date: 2019-02-08
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: IntegraMed Medical - King, PLLC in Las Vegas, NV, was cited for significant deficiencies in its human tissue establishment operations. The inspection revealed failures in donor screening for communicable diseases, inadequate labeling of HCT/Ps, and poorly defined standard operating procedures for donor eligibility. Additionally, donor eligibility records were found to be inaccurate regarding who performed the final determinations.

## 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-nevada-fertility-center-pc/bc5b7d84-a4a2-4a07-9239-6f970f462022

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