1Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
Inspection Record
DMVet Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Stability and storage
The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.
4Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
5Stability 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.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
8Complaint and recall handling
The written recall system did not include distribution records that allowed each drug to be traced.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-07-15. 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.
