1Other quality system
The recorded information or details were inadequate.
Inspection Record
Church & Dwight Canada Corp. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The maintenance of records was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
4Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
5Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
7Quality unit oversight
The annual product quality review procedure was inadequate.
8Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
10Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
11Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
12Other quality system
The master formulas to control the manufacturing process were inadequate. Yields and/or the reconciled quantities were not checked at appropriate stages.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-09-27. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
