Taro Pharmaceuticals Inc — Health Canada Inspection Findings

Investigations into deviations, reports, and/or follow-up actions were inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The receipt, preparation, and/or handling of reagents and culture media was inadequate.

The quality control department did not undertake all of the required activities.

The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The analysis of trends for batches of drugs that differed from the norm was inadequate.