1Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
Inspection Record
Innomar Strategies Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Other quality system
The distribution records did not allow each drug to be traced individually.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
7Other quality system
The assessment to release finished products was inadequate.
8Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-11. 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.
