FDA Inspection 1034753 — Charter Medical LLC

Charter Medical LLC — FEI 3002910717

The FDA completed an inspection of Charter Medical LLC on December 11, 2017 in Winston Salem, NC. 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
December 11, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Winston Salem, NC (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures