1Equipment and facility
The receipt, preparation, and/or handling of reagents and culture media was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate.
Inspection Record
Altea Farmaceutica SA — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
3Equipment and facility
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
4Laboratory and QC controls
The establishment and/or the maintenance of a data governance plan was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
5Material and supplier control
The sampling plan for raw materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-09-11. 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.
