FDA Inspection 1210401 — BrainScope Company, Inc.

BrainScope Company, Inc. — FEI 3008660657

The FDA completed an inspection of BrainScope Company, Inc. on July 13, 2023 in Chevy Chase, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 13, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Chevy Chase, MD (United States)