1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The recorded information or details were inadequate.
Inspection Record
Shields Pharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Equipment and facility
The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-07-25. 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.
