1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
Inspection Record
Oxymed, Div. De 118303 Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
3Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
7Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The recorded information or details were inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The master formula for packaged products did not include the required information.
9Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
10Complaint and recall handling
The written recall system did not include distribution records that allowed each drug to be traced.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-11-07. 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.
