1Complaint and recall handling
The written procedures for recalls were inadequate.
Inspection Record
Galenova Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
5Other quality system
Active Pharmaceutical Ingredients were manufactured and tested from companies for which GMP compliance information was not available.
6Other quality system
The electronic system was not validated for its intended use.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Training and personnel
The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.
10Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-03. 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.
