1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Drucan Trading Corp. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The electronic system was not validated for its intended use.
3Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
4Other quality system
Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
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 2023-06-20. 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.
