1Stability and storage
The ongoing stability program for a drug was inadequate.
Inspection Record
Zochem ULC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Quality unit oversight
The annual product quality review procedure was inadequate.
7Other quality system
The recorded information or details were inadequate. The assessment to release finished products was inadequate.
8Material and supplier control
The company did not store a sample from each lot or batch of a drug, raw material, and/or an active ingredient under the proper conditions. The written procedures and records for retaining samples were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-03-03. 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.
