1Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
Inspection Record
Opella Canada 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 specifications approved by the quality control department were not available for all raw materials used to produce drugs. The drug fabricator's specifications for raw materials were inadequate.
3Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Other quality system
The assessment to release finished products was inadequate.
5Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
6Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
7Material and supplier control
A sample from each lot of raw materials was not fully tested against the specifications. Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The maintenance of personnel records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-09-13. 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.
