1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Ichor Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Specific identity testing was not conducted on all lots of raw materials received on the premises. Complete confirmatory testing was not conducted on raw materials from each vendor. The specifications approved by the quality control department were not available for all raw materials used to produce drugs.
3Laboratory and QC controls
The written specifications were inadequate. Test methods were not validated or the method transfer studies were not conducted.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
6Equipment and facility
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The preventative maintenance and repair of the equipment was inadequate.
7Equipment and facility
Critical production processes were not validated. Evaluation of production processes, equipment, and/or materials was inadequate.
8Other quality system
The assessment to release finished products was inadequate.
9Equipment and facility
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend . "The maintenance of records was inadequate.
10Documentation and records
The master formulas to control the manufacturing process were inadequate. The master production documents were inadequate. As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.
11Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
12Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-08-11. 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.
