1Training and personnel
The written hygiene program was not being followed by plant personnel and/or visitors.
Inspection Record
Kopran Research Laboratories Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
5Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
6Cleaning 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.
7Material and supplier control
The handling of standard operating procedures for good manufacturing practices was inadequate. The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
8Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-24. 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.
