# FDA 483 - Pacific Northwest Fertility and IVF Specialists, PLLC - February 18, 2020

Source: https://www.keypedia.com/records/483/pacific-northwest-fertility-and-ivf-specialists-pllc/e284074f-3c31-420f-8520-59129cfc6c02

> FDA 483 for Pacific Northwest Fertility and IVF Specialists, PLLC on February 18, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacific Northwest Fertility and IVF Specialists, PLLC
- Inspection Date: 2020-02-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Pacific Northwest Fertility and IVF Specialists, I, PLLC in Seattle revealed deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) operations. The firm failed to adequately determine donor eligibility, specifically regarding screening for Transmissible Spongiform Encephalopathies (TSE). Additionally, the firm did not properly document reasons for donor ineligibility in their records, a repeat observation from a previous inspection.

## Related Officers

- [Investigator](https://www.keypedia.com/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.keypedia.com/companies/pacific-northwest-fertility-and-ivf-specialists-pllc/b73a2622-a90b-4c26-b335-072842d08514

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822