1Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
Inspection Record
Belvedere International 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 handling of standard operating procedures for good manufacturing practices was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Other quality system
The implementation of a self-inspection program was inadequate.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Material and supplier control
The master production documents were inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The verification and dispensing of raw materials by qualified staff was inadequate.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
10Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
11Training and personnel
The written hygiene program was not being followed by plant personnel and/or visitors.
12Computer system validation
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 2022-06-01. 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.
