1Documentation and records
As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.
Inspection Record
Pharmascience Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate. The validation of aseptic processing was inadequate.
5Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
6Other quality system
The written clothing standards for each environmental grade were inadequate.
7Other quality system
The written sanitation program for clean areas was inadequate.
8Other quality system
The company's visual inspection of filled containers was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-03-20. 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.
