1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Macleods Pharmaceuticals Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
3Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
4Other quality system
The recorded information or details were inadequate.
5Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate. The maintenance of records was inadequate.
6Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-05-05. 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.
