1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Arthropharm Pharmaceuticals Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The handling of rejected materials and products was inadequate.
3Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Other quality system
Documents were not available on the premises.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Other quality system
The implementation of a self-inspection program was inadequate.
8Material and supplier control
The company did not determine the stability of the drug before it was marketed or before significant changes were made to the drug formulations, fabrication procedures, or packaging materials.
9Other quality system
The assessment to release finished products was inadequate.
10Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
11Stability and storage
The ongoing stability program for a drug was inadequate.
12Labeling 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).
13Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The ongoing training of personnel was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
14Other quality system
The written procedures and records for retaining samples were inadequate.
15Laboratory and QC controls
The quality control department was not involved in all decisions for the quality of the product.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-05-27. 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.
