1Labeling and packaging
The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
Inspection Record
sanofi-aventis Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Material and supplier control
Bulk drugs, in-process drugs, raw materials, or packaging materials were not labelled with all the required information.
5Equipment and facility
"The maintenance of records was inadequate. The ongoing stability program for a drug was inadequate.
6Other quality system
The assessment to release finished products was inadequate.
7Quality unit oversight
The annual product quality review procedure was inadequate.
8Other quality system
The master production documents were inadequate. Documents were not available in one of the official languages. The recorded information or details were inadequate.
9Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
10Laboratory and QC controls
The evidence required to demonstrate compliance with finished product specifications was inadequate. Confirmatory testing was not performed by an alternate laboratory. The availability or the content of the authentic certificate of analysis was inadequate. The content of the batch certificate was inadequate.
11Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
12Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-27. 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.
