Piramal Healthcare (Canada) Limited — Health Canada Inspection Findings

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

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

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

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.