Teamworks Manufacturing — Health Canada Inspection Findings

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The education, experience, and/or oversight of the individual in charge of the manufacturing 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 recorded information or details were inadequate.

The control of quarantine areas was inadequate.

The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

The handling of standard operating procedures for good manufacturing practices was inadequate.

The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.

The contracted testing site did not have a valid establishment license.

The company did not determine the stability of the drug before it was marketed or before significant changes were made to the drug formulations, fabrication procedures, or packaging materials.

Lots and/or batches of packaging materials were not examined and/or tested against the written specifications before they were used.