1Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
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
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Cleaning validation
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Equipment and facility
The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. Validation studies were not conducted in keeping with the predefined protocols.
7Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-01-09. 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.
