1Labeling and packaging
The implementation of minimum health and hygiene requirements for personnel was inadequate for ensuring the clean and sanitary fabrication, packaging, and/or labelling of drugs.
Inspection Record
Labomar Canada 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
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. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Stability 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.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Equipment and facility
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.
7Other quality system
The implementation of a self-inspection program was inadequate.
8Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Other quality system
Critical production processes were not validated.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-06-10. 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.
