1Training and personnel
The ongoing training of personnel was inadequate.
Inspection Record
Kohl & Frisch Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The implementation of a self-inspection program was inadequate.
3Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
5Equipment and facility
The maintenance of records was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
8Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
9Stability and storage
The temperature and/or humidity control was inadequate.
10Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-16. 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.
