1Equipment and facility
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
Inspection Record
Atlas Pharma 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 validation and/or the documentation of test methods was inadequate.
3Deviation, 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.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-12-17. 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.
