Viva Pharmaceutical Inc. — Health Canada Inspection Findings

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

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

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate. The maintenance of records 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 preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.

The design, equipment, and/or maintenance of the testing laboratory was inadequate.

The sampling plan for raw materials was inadequate.

The maintenance of the premises was inadequate. The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions. The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.

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

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

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