FDA Inspection 907002 — TSO3 Inc.

TSO3 Inc. — FEI 3004148947

The FDA completed an inspection of TSO3 Inc. on December 11, 2014 in Quebec. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 11, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Quebec (Canada)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
316021 CFR 820.184Lack of or inadequate DHR procedures