1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
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
2Laboratory and QC controls
The quality control department did not undertake all of the required activities.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Equipment and facility
The preventative maintenance and repair of the equipment was inadequate. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.
5Equipment and facility
The qualification and/or verification of utilities and/or support systems was inadequate. The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
6Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
7Equipment and facility
The maintenance of records was inadequate.
8Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-08-20. 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.
