1Stability 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.
Inspection Record
Lynden International Logistics ULC — 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.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Laboratory and QC controls
The quality control department's documentation, labelling, and/or quarantining of raw materials, packaging materials, in-process drugs, and/or bulk drugs was inadequate. Packaging operations were not performed in keeping with the written operating procedures or specifications.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-07. 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.
