1Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
Inspection Record
Grifols Canada Therapeutics Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Other quality system
The sampling, testing, and/or specifications for total microbial count were inadequate.
5Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
6Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The availability, implementation, and/or quality of the written sanitation program was inadequate.
7Other quality system
The company's visual inspection of filled containers was inadequate.
8Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
10Aseptic processing and sterility assurance
The company's monitoring and documentation of heat sterilization cycles was inadequate.
11Aseptic processing and sterility assurance
The process was inadequate for the environmental classification of aseptic or clean areas.
12Material 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 for the required amount of time.
13Aseptic processing and sterility assurance
The company did not monitor the steam used for sterilization for suitable quality.
14Complaint and recall handling
The written procedures for recalls were inadequate.
15Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
16Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
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.
