1Other quality system
The recorded information or details were inadequate.
Inspection Record
Medline Canada Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling 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).
3Other quality system
The assessment to release finished products was inadequate.
4Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
7Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-08-26. 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.
