1Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
Inspection Record
North China Pharmaceutical Group Semisyntech Co., Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
4Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
5Laboratory and QC controls
The quality control department did not undertake all of the required activities.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-01-20. 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.
