1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Mylan Pharmaceuticals ULC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Confirmatory testing was not performed by an alternate laboratory.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-11-07. 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.
