Taro Pharmaceuticals Inc — Health Canada Inspection Findings

The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.

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

The traceability, legibility, documentation, formatting, and/or the accuracy of records 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 monitoring procedures for microbial and/or environmental conditions were inadequate.

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.

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 drug was fabricated, packaged, labelled, and/or stored in premises that were not designed, constructed, and/or maintained to allow for effective cleaning, sanitary conditions, and/or the prevention of drug contamination.

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

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

The evidence required to demonstrate compliance with finished product specifications was inadequate.