Viva Pharmaceutical Inc. — Health Canada Inspection Findings

The written specifications were inadequate.

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

The recorded information or details were inadequate.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

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

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

The maintenance of distribution records for drugs was inadequate.

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

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.