1Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
Inspection Record
Baxter Healthcare Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The company's monitoring of water testing was inadequate.
3Aseptic processing and sterility assurance
The company's visual inspection of filled containers was inadequate. The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
4Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
5Equipment and facility
The operation of the water purification equipment was inadequate for ensuring a reliable source of water.
6Environmental monitoring
The number of samples taken for environmental monitoring was insufficient.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
8Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
9Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
10Laboratory and QC controls
The quality control department did not undertake all of the required activities.
11Aseptic processing and sterility assurance
The company's validation of moist heat sterilization was inadequate.
12Material and supplier control
Precautions were not taken to ensure that containers were free from contamination by foreign material.
13Deviation, CAPA, and investigation
The company's investigations of microbial contamination in critical areas were inadequate.
14Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-15. 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.
