Baxter Corporation — Health Canada Inspection Findings

The company did not take precautions to minimize contamination during all processing prior to sterilization.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

The testing or examination of packaging materials was inadequate on a sample received on the premises by a person that packages the drugs.

The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose

The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

The recorded information or details were inadequate.

The company's visual inspection of filled containers was inadequate.

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

Critical processes and procedures were not evaluated on a regular basis. Evaluation of production processes, equipment, and/or materials was inadequate.

The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate.

Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test. The sampling plan for raw materials was inadequate.