907193

Mondelez Canada Inc. — FEI 3009766945

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 21, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Scarborough (Canada)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
191221 CFR 211.166(a)Written program not followed
431421 CFR 211.84(d)(2)Reports of Analysis (Components)