1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Les Emballages Façoteck Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
3Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
4Equipment and facility
The maintenance and/or monitoring of the ventilation system's air quality was inadequate. The qualification and/or verification of utilities and/or support systems was inadequate. The premises were not laid out and/or designed to ensure that production areas were adequately isolated and segregated. The control of quarantine areas was inadequate.
5Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The recorded information or details were inadequate.
6Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
7Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test. The sampling plan for raw materials was inadequate.
8Stability and storage
The temperature and/or humidity control was inadequate.
9Material and supplier control
The specifications for any packaging materials were incomplete or inadequate.
10Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
11Other quality system
The written self-inspection procedure was inadequate. The implementation of a self-inspection program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-09-13. 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.
