1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Baxter Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The identity testing of primary packaging materials once they were received on the premises by a person that packages the drugs was inadequate.
3Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization. The condition of the clean area used to produce sterile products was inadequate. The written sanitation program for clean areas was inadequate. The company's visual inspection of filled containers was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
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
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
10Laboratory and QC controls
The assessment to release finished products was inadequate. The quality control department's approval was inadequate for raw materials, packaging materials, labelling, finished products, and/or products being reprocessed.
11Material and supplier control
The sampling plan for raw materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-09-27. 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.
