1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Occy Laboratoire Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
3Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
4Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
5Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Other quality system
The implementation of a self-inspection program was inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
10Equipment and facility
The maintenance of detailed plans or specifications was inadequate for each building where drugs are fabricated, packaged, labelled, and/or tested.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-11-09. 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.
