1Stability and storage
The stability program did not include batches of drugs that had been stored for extended periods of time before they were packaged.
Inspection Record
AbbVie Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The company's oversight of the contracted party was inadequate.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Complaint and recall handling
The quality control department did not undertake all of the required activities. The quality control department's handling of complaints and/or information received about drug quality was inadequate.
5Deviation, 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.
6Other quality system
The written specifications were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-07-18. 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.
