1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Factors Group of Nutritional Companies 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 evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
3Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Equipment and facility
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Other quality system
The assessment of the contractor's competencies by the fabricator, packager/labeller, distributor, or importer was inadequate.
6Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate. The method for re-testing identified failures and/or re-qualifying raw material vendors was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Laboratory and QC controls
The electronic system was not validated for its intended use. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The design, equipment, and/or maintenance of the testing laboratory was inadequate.
9Other quality system
The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.
10Other quality system
The company's monitoring of water testing was inadequate.
11Other quality system
Measures to ensure the compliance of the contracted test laboratories were inadequate.
12Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
13Documentation and records
As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.
14Laboratory and QC controls
The specifications approved by the quality control department were not available for all raw materials used to produce drugs.
15Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
16Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-05. 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.
