SC Johnson Professional CA Inc. — Health Canada Inspection Findings

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

The temperature and/or humidity control was inadequate.

The ongoing stability program for a drug was inadequate.

The written specifications were inadequate.

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The company did not adequately validate the analytical test procedures used in the stability program.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug. The usage logs for the equipment used for significant processing and/or testing operations were inadequate. The operation of the water purification equipment was inadequate for ensuring a reliable source of water.

The availability or the content of the authentic certificate of analysis was inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The annual product quality review procedure was inadequate.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

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

Complete confirmatory testing was not conducted on raw materials from each vendor.

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. 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 quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.

Evaluation of production processes, equipment, and/or materials was inadequate. The recorded information or details were inadequate. The master production documents were inadequate.