Emballages Mitchel Lincoln Ltée — Health Canada Inspection Findings

The master formulas to control the manufacturing process were inadequate. The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate. Printed packaging materials were not stored in an area with restricted access. The handling of rejected materials and products was inadequate.

The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.

The training, experience, and/or delegated duties for the individual responsible for labelling operations and/or the quality control department of a secondary labeller were inadequate.

The maintenance of the premises was inadequate. The temperature and/or humidity control was inadequate.

Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.

The electronic system was not validated for its intended use. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.