1Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
Inspection Record
Thunder Bay Regional Health Sciences Centre — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The ongoing training of personnel was inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Stability 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.
5Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
8Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
9Material and supplier control
A reduced retesting program for raw materials was in place without the raw material vendor certification.
10Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
11Material and supplier control
The company did not retain a sample of each lot or batch of a drug, raw material, and/or an active ingredient.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-07-08. 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.
