1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was 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
2Material and supplier control
The protection of products and/or materials from contamination 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 sampling plan for raw materials was inadequate. The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
7Laboratory and QC controls
The validation of test methods was inadequate.
8Stability and storage
The temperature and/or humidity control was inadequate.
9Laboratory 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 2022-10-24. 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.
