1Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
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
2Laboratory 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.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Laboratory and QC controls
The quality control department did not undertake all of the required activities.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Equipment 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 2022-11-24. 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.
