1Laboratory and QC controls
The validation of test methods was inadequate.
Inspection Record
Novocol Pharmaceutical of 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 investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-26. 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.
