1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
Accel Pharma Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The ongoing stability program for a drug was inadequate.
3Other quality system
The recorded information or details were inadequate.
4Other quality system
The controls put in place for electronic signatures were inadequate.
5Complaint and recall handling
The written procedures for recalls were inadequate.
6Labeling and packaging
Periodic confirmatory testing was not conducted. The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate. The availability or the content of the authentic certificate of analysis was inadequate.
7Laboratory and QC controls
The quality control department did not undertake all of the required activities.
8Equipment 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.
9Complaint 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 2021-04-12. 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.
