1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
BioVectra Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Equipment and facility
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
6Other quality system
Measures to ensure the compliance of the contracted test laboratories were inadequate.
7Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-26. 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.
