1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Macco Organiques Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Equipment and facility
The maintenance of records was inadequate.
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-08-27. 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.
