1Equipment and facility
The operation of the water purification equipment was inadequate for ensuring a reliable source of water.
Inspection Record
Apotex Pharmachem Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Laboratory and QC controls
The company did not adequately validate the analytical test procedures used in the stability program.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
6Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
7Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
8Labeling 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).
9Material and supplier control
The method for re-testing identified failures and/or re-qualifying raw material vendors was inadequate.
10Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
11Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
12Complaint and recall handling
Health Canada was not notified of a recall.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-03-03. 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.
