Pacific Northwest Fertility and IVF Specialists, PLLCFebruary 18, 2020

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

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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.

Company: Pacific Northwest Fertility and IVF Specialists, PLLC
Inspection Date: February 18, 2020
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West VI
Person: Peter S. Kessler (Investigator)

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ID · e284074f-3c31-420f-8520-59129cfc6c02