FDA Inspection 1107481 — Teva Canada Limited

Teva Canada Limited — FEI 3002807756

The FDA completed an inspection of Teva Canada Limited on October 25, 2019 in Scarborough. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 25, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Scarborough (Canada)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
191721 CFR 211.166(a)(1)Sample size - test intervals