1Other quality system
Critical production processes were not validated.
Inspection Record
Novartis Pharmaceuticals Canada Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The quality control department did not undertake all of the required activities.
3Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
6Labeling and packaging
The availability or the content of the authentic certificate of analysis was inadequate. The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate. Periodic confirmatory testing was not conducted.
7Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The maintenance of records was inadequate.
8Other quality system
The implementation of a self-inspection program was inadequate.
9Stability and storage
The frequency of stability testing of a drug did not comply with the marketing authorization. The ongoing stability program for a drug was inadequate.
10Laboratory and QC controls
The product was made available for sale without the approval of the quality control department.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-12-06. 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.
