FDA Inspection 918934 — Element Materials Technology Canada Inc.

Element Materials Technology Canada Inc. — FEI 3002807812

The FDA completed an inspection of Element Materials Technology Canada Inc. on February 9, 2015 in Mississauga. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 9, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mississauga (Canada)

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors