FDA Inspection 1037507 — Sound Fertility Care PLLC

Sound Fertility Care PLLC — FEI 3011419985

The FDA completed an inspection of Sound Fertility Care PLLC on January 12, 2018 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 12, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Seattle, WA (United States)

Citations

IDCFRDescription
1223121 CFR 1271.50(b)(1)Donor screening standards
1228621 CFR 1271.80(b)Specimen collections not timely