1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Pfizer Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The validation of test methods was inadequate.
3Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-07. 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.
