1Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
Inspection Record
Cerapie Pharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Stability and storage
The temperature and/or humidity control was inadequate. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
5Material and supplier control
The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate. The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
6Other quality system
Documents were not available on the premises.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-10. 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.
