1Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
Inspection Record
Canadian Blood Services — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The identification and storage of recalled products was inadequate. The written procedures for recalls were inadequate.
3Material and supplier control
The premises were not laid out and/or designed for an optimal flow of personnel and/or materials to prevent cross-contamination and/or mix-ups between products.
4Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
5Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Other quality system
The control of quarantine areas was inadequate.
8Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-18. 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.
