1Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were inadequate.
Inspection Record
Apotex Pharmachem 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 handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate. The recorded information or details were inadequate.
3Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
4Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The recorded information or details were inadequate. The maintenance of records was inadequate.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Computer system validation
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-09-09. 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.
