1Stability and storage
The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.
Inspection Record
MNK Recherches 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.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted. The availability or the content of the authentic certificate of analysis was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Quality unit oversight
The annual product quality review procedure was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-08-03. 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.
