1Other quality system
The recorded information or details were inadequate.
Inspection Record
Biomed Pharma — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The written self-inspection procedure was inadequate. The implementation of a self-inspection program was inadequate.
3Laboratory and QC controls
The quality control department did not undertake all of the required activities. Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
4Other quality system
The controls put in place for electronic signatures were inadequate.
5Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
6Laboratory and QC controls
Confirmatory testing was not performed by an alternate laboratory.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-10. 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.
