FDA Inspection 1034441 — Church & Dwight Canada Corp.

Church & Dwight Canada Corp. — FEI 1000657351

The FDA completed an inspection of Church & Dwight Canada Corp. on December 8, 2017 in Mont-Royal. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 8, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mont-Royal (Canada)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
356521 CFR 211.58Buildings not maintained in good state of repair
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action