1Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
Inspection Record
Steri-Med Pharma 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 airborne particle monitoring system was inadequate.
3Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
4Other quality system
Yields and/or the reconciled quantities were not checked at appropriate stages.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Other quality system
The master formulas to control the manufacturing process were inadequate.
7Material and supplier control
Testing was not performed after raw materials were received on the premises of the drug fabricator.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization.
10Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-11-06. 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.
