1Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
Inspection Record
Unichem Laboratories Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Validation studies were not conducted in keeping with the predefined protocols. Evaluation of production processes, equipment, and/or materials was inadequate. The recorded information or details were inadequate.
3Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
4Laboratory and QC controls
The company did not adequately validate the analytical test procedures used in the stability program.
5Cleaning 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. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
6Other quality system
A document was not issued for each vendor verifying the vendor meets the criteria for certification.
7Laboratory and QC controls
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The design, equipment, and/or maintenance of the testing laboratory was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-09-23. 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.
