1Equipment and facility
The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions. The maintenance and/or monitoring of the ventilation system's air quality was inadequate.
Inspection Record
Protein Sciences, a Sanofi Company — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Material and supplier control
The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.
7Other quality system
The master production documents were inadequate. The recorded information or details were inadequate.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
9Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
10Stability 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.
11Equipment and facility
The protection of products and/or materials from contamination was inadequate. Evaluation of production processes, equipment, and/or materials was inadequate.
12Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-12. 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.
