1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Altius Healthcare Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The ongoing stability program for a drug was inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Other quality system
Documents were not available on the premises.
5Equipment and facility
The training of personnel before new or revised standard operating procedures were implemented was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-14. 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.
