Apotex Inc — Health Canada Inspection Findings

Evaluation of production processes, equipment, and/or materials was inadequate.

The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, 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 written sanitation program for clean areas was inadequate. The company's cleaning of the premises and the equipment in aseptic areas was inadequate.

The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas. The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.

The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas. The company did not adequately monitor the clean areas used for the less critical stages of manufacturing sterile products.