1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
AstraZeneca Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate. The content of the batch certificate was inadequate.
3Quality unit oversight
The annual product quality review procedure was inadequate.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
6Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
7Equipment and facility
"The maintenance of records was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-12. 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.
