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).
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Health Canada Labeling and packaging findings
by this agency in this category 221 findings drawn from 197 published documents. The most recent cases are below; the full set is in search.
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Recent findings
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).
View official sourceThe handling of standard operating procedures for good manufacturing practices was inadequate. The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
See every finding in this document View official sourceThe 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).
See every finding in this document View official sourceThe positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
View official sourceThe 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).
See every finding in this document View official sourceOther agencies
These findings are a record of the moment each document was published. 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 them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-09-04, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
