1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Medreich Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Yields and/or the reconciled quantities were not checked at appropriate stages.
3Material and supplier control
The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Quality unit oversight
The annual product quality review procedure was inadequate.
6Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-10-11. 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.
