1Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
Inspection Record
Gilead Sciences Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
3Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. Evaluation of production processes, equipment, and/or materials was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
6Deviation, CAPA, and investigation
The creation, maintenance, processing, and/or review of laboratory data was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Deviation, CAPA, and investigation
When the particulate and microbiological limits were exceeded, the company's operating procedures did not prescribe an investigation and implementation of corrective actions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-18. 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.
