1Quality unit oversight
The annual product quality review procedure was inadequate.
Inspection Record
Alk-Abello Pharmaceuticals 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 availability or the content of the authentic certificate of analysis was inadequate. The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Stability 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.
5Stability and storage
The ongoing stability program for a drug was inadequate.
6Equipment and facility
The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-03-12. 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.
