1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Delpharm Boucherville Canada 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
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Stability and storage
The receipt, preparation, and/or handling of reagents and culture media was inadequate. The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-08. 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.
