1Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
Inspection Record
Groupe Parima Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The availability, implementation, and/or quality of the written sanitation program was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Material and supplier control
Printed packaging materials were not stored in an area with restricted access. The handling of rejected materials and products was inadequate.
5Material and supplier control
The sampling plan for raw materials was inadequate.
6Material and supplier control
The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.
7Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Other 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 2024-04-15. 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.
