1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Greer Laboratories, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Other quality system
The environmental sampling methods were inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Other quality system
Critical production processes were not validated.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
8Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
9Laboratory and QC controls
The quality control department did not undertake all of the required activities.
10Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-15. 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.
