1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Euro-Pharm International Canada Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The implementation of a self-inspection program was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Equipment 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.
5Other quality system
The controls put in place for electronic signatures were inadequate.
6Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
7Other quality system
Critical production processes were not validated.
8Complaint and recall handling
The written procedures for recalls were inadequate.
9Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
10Quality unit oversight
The annual product quality review procedure was inadequate.
11Stability and storage
The ongoing stability program for a drug was inadequate.
12Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
13Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
14Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
15Labeling 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-22. 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.
