1Stability and storage
The temperature and/or humidity control was inadequate.
Inspection Record
Methapharm Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
For imported products, the stability studies from foreign sites were not compliant with Canadian good manufacturing practices and/or Canadian marketing authorization.
3Labeling and packaging
Packaging operations were not performed in keeping with the written operating procedures or specifications.
4Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Other quality system
The assessment to release finished products was inadequate.
8Other quality system
The implementation of a self-inspection program was inadequate.
9Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
10Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
11Stability and storage
The ongoing stability program for a drug was inadequate.
12Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
13Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
14Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-02-02. 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.
