1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
Le Groupe Ultrapac — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
5Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
6Quality unit oversight
The annual product quality review procedure was inadequate.
7Stability and storage
The temperature and/or humidity control was inadequate.
8Computer system validation
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.
9Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired. The drug fabricator's specifications for raw materials were inadequate. The specifications for raw materials did not contain microbial content specifications from a recognized pharmacopoeia.
10Material and supplier control
The specifications for any packaging materials were incomplete or inadequate.
11Equipment and facility
The maintenance and/or monitoring of the ventilation system's air quality was inadequate.
12Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
13Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
14Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
15Equipment and facility
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
16Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
17Equipment and facility
Bulk drugs, in-process drugs, raw materials, or packaging materials were not labelled with all the required information. Evaluation of production processes, equipment, and/or materials was inadequate.
18Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
19Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
20Equipment and facility
The preventative maintenance and repair of the equipment was inadequate. The temperature and/or humidity control was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-01-12. 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.
