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FDA Inspection
•Mondelez Canada•November 21, 2014

Mondelez Canada – FDA Inspection, Nov 21, 2014

Record Details

This FDA Inspection record concerns Mondelez Canada, with an inspection on November 21, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mondelez Canada
Inspection Date
November 21, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 06b69d00-1a60-4b89-9537-1aaf4d4900eb

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
907193
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

7
  1. 21 CFR 211.68(b)Computer control of master formula records
  2. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  3. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  4. 21 CFR 211.165(a)Testing and release for distribution
  5. 21 CFR 211.100(a)Absence of Written Procedures
  6. 21 CFR 211.22(d)Procedures not in writing, fully followed
  7. 21 CFR 211.166(a)Written program not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mondelez Canada

2
DateClassificationOfficeProject area
May 22, 2025Not classifiedOffice of Inspections and Investigations
August 29, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mondelez Canada
  • FDA Inspection 1274532 - 2025-05-22
  • FDA Inspection 1105859 - 2019-08-29

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