1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
Stallergenes Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
5Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Laboratory and QC controls
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
11Quality unit oversight
The annual product quality review procedure was inadequate.
12Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-12-01. 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.
