1Other quality system
The recorded information or details were inadequate.
Inspection Record
Fratum Pharma Inc. (Division of Euro-Pharm International Canada 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.
3Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
4Equipment and facility
The maintenance of personnel records was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
7Labeling and packaging
The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
8Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-30. 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.
