FDA Inspection 680578 — Teva Canada Limited

Teva Canada Limited — FEI 3002807742

The FDA completed an inspection of Teva Canada Limited on July 29, 2010 in Markham. 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
July 29, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Markham (Canada)

Citations

IDCFRDescription
186921 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings