FDA Inspection 680233 — Kenvue Canada Inc.

Kenvue Canada Inc. — FEI 1000328785

The FDA completed an inspection of Kenvue Canada Inc. on July 23, 2010 in Guelph. 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 23, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Guelph (Canada)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
438921 CFR 211.198(a)Procedures to be written and followed