1Other quality system
The availability or the content of the authentic certificate of analysis was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
The Mentholatum Company of Canada Ltd — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The handling of standard operating procedures for good manufacturing practices was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
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).
4Laboratory and QC controls
Confirmatory testing was not performed by an alternate laboratory.
5Equipment and facility
The maintenance of records was inadequate. The electronic system was not validated for its intended use.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-22. 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.
