1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Catalent Micron Technologies 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 implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
5Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
6Material and supplier control
The standard operating procedures or records for shipping and receiving raw materials were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-03. 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.
