1Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
Inspection Record
Quantum Pharma Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
3Other quality system
The written specifications were inadequate.
4Contamination control
The drug was fabricated, packaged, labelled, and/or stored in premises that were not designed, constructed, and/or maintained to allow for effective cleaning, sanitary conditions, and/or the prevention of drug contamination.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Other quality system
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 2021-02-16. 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.
