Sandoz Canada Incorporated — Health Canada Inspection Findings

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The evidence required to demonstrate compliance with finished product specifications was inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.