1Material and supplier control
Lots and/or batches of packaging materials were not examined and/or tested against the written specifications before they were used.
Inspection Record
Abbott Laboratories Co. — 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.
3Equipment and facility
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Training and personnel
The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-09-23. 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.
