FDA Inspection 1227150 — Global Blood Resources, LLC

Global Blood Resources, LLC — FEI 3004080795

The FDA completed an inspection of Global Blood Resources, LLC on January 17, 2024 in Windsor, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 17, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Windsor, CT (United States)

Citations

IDCFRDescription
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation