1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Amorepacific Canada Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The master production documents were inadequate.
3Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
4Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
5Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
6Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
7Other quality system
Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-07-28. 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.
