1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Meridian Medical Technologies, LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
3Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate. The written sanitation program for clean areas was inadequate.
4Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-09-11. 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.
