1Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
Inspection Record
Delta Pharma 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. The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
3Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
4Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
5Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was 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. The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Other 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.
9Equipment and facility
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The maintenance of personnel records was inadequate.
10Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
11Other quality system
The implementation of a self-inspection program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-04-19. 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.
