1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Sterimax Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Equipment and facility
The maintenance of records was inadequate.
4Stability and storage
The temperature and/or humidity control was inadequate.
5Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
6Labeling and packaging
The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
7Equipment 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.
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).
9Other quality system
Complete testing was not performed according to the requirements.
10Other quality system
The assessment to release finished products was inadequate.
11Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
12Labeling and packaging
Packaging operations were not performed in keeping with the written operating procedures or specifications.
13Stability and storage
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend . The ongoing stability program for a drug was inadequate.
14Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review. The annual product quality review procedure was inadequate.
15Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
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.
