Sound Fertility Care PLLCFebruary 6, 2020

FDA 483 - Sound Fertility Care PLLC - February 06, 2020

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Record Details

Sound Fertility Care PLLC in Seattle, WA, was inspected regarding its human reproductive tissue operations, revealing two significant observations. The firm's donor eligibility records for sperm and oocyte donors were found to be inaccurate, with errors in determination dates and missing risk assessments. Additionally, the facility failed to adhere to its standard operating procedure for releasing HCT/Ps from donors reactive for cytomegalovirus.

Company: Sound Fertility Care PLLC
Inspection Date: February 6, 2020
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West VI
Person: Peter S. Kessler (Investigator)

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ID · b278adf4-b8c3-4998-b5d2-551b1a832c1a