1Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
Inspection Record
National Research Council of Canada (Biologics Manufacturing Centre) / Conseil national de recherches Canada (Centre de production de produits biologiques) — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
3Equipment and facility
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
4Validation and qualification
The working spaces were inadequate. The qualification and/or verification of utilities and/or support systems was inadequate. The control of quarantine areas was inadequate.
5Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate. The monitoring procedures for microbial and/or environmental conditions were inadequate.
6Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
7Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
8Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-07-18. 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.
