Empack Spraytech Inc. — Health Canada Inspection Findings

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

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

The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

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

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

The implementation of a self-inspection program was inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.

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

The handling of standard operating procedures for good manufacturing practices was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.