1Complaint and recall handling
The quality control department did not ensure a thorough investigation and/or evaluation of complaints concerning potentially defective products.
Inspection Record
Nordion (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 quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
3Laboratory and QC controls
The electronic system was not validated for its intended use. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Equipment and facility
A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations
5Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
6Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-02-01. 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.
