1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Lallemand Health Solutions Inc./Lallemand Solutions Santé Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Other quality system
The implementation of a self-inspection program was inadequate.
6Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
7Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Complaint and recall handling
The written procedures for recalls were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-01-23. 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.
