1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
Inspection Record
Enviro-Health Research Laboratories Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The recorded information or details were inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
3Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
6Computer system validation
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-01-25. 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.
