FDA Inspection 1036573 — Control Solutions, LLC.

Control Solutions, LLC. — FEI 3003230048

The FDA completed an inspection of Control Solutions, LLC. on Nov 20, 2017 in Aurora, IL. 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Nov 20, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Aurora, IL (United States)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
383721 CFR 820.25(b)Training records