1Equipment 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.
Inspection Record
Liebel-Flarsheim Canada 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.
3Labeling 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).
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.
5Equipment and facility
"The maintenance of records was inadequate.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
8Laboratory and QC controls
The written protocol and/or the assessment of the test method transfer was inadequate.
9Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
10Other quality system
The assessment to release finished products was inadequate.
11Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
12Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-12. 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.
