1Stability and storage
The ongoing stability program for a drug was inadequate.
Inspection Record
Primera Analytical Solutions Corp. — 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.
3Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Equipment and facility
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The preventative maintenance and repair of the equipment was inadequate.
6Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
9Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-04. 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.
