1Other quality system
The assessment to release finished products was inadequate.
Inspection Record
AX Pharmaceutical Corp — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The written procedures for recalls were inadequate.
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).
4Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
5Laboratory and QC controls
The validation of test methods was inadequate.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Quality unit oversight
The annual product quality review procedure was inadequate.
8Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
9Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
10Stability and storage
The ongoing stability program for a drug was inadequate.
11Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
12Deviation, 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.
13Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
14Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-29. 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.
