1Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
Inspection Record
SGS Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
3Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate. Sterile disinfectants were not used in Grade A and B areas.
5Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
6Deviation, CAPA, and investigation
The validation of test methods was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-20. 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.
