1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Canadian Analytical Laboratories division of Reena Group 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
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Laboratory and QC controls
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were inadequate.
6Laboratory and QC controls
The validation of test methods was inadequate.
7Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-24. 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.
