1Other quality system
Critical processes and procedures were not evaluated on a regular basis.
Inspection Record
Baxter Corporation — 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. The company's visual inspection of filled containers was inadequate.
3Aseptic processing and sterility assurance
The company's validation of moist heat sterilization was inadequate.
4Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
6Laboratory and QC controls
The quality control department was not involved in all decisions for the quality of the product.
7Other quality system
The recorded information or details were inadequate.
8Training and personnel
The ongoing training of personnel was inadequate.
9Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
10Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
11Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
12Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-09-11. 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.
