1Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
Inspection Record
Laboratoire Atlas 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 temperature and/or humidity control was inadequate.
3Material and supplier control
The handling of rejected materials and products was inadequate.
4Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
5Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
6Labeling 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).
7Equipment and facility
A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations
8Stability 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.
9Other quality system
The written specifications were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-08-23. 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.
