GSK Statement: Health Canada Inspection Summary Report – Ste-Foy Manufacturing Facility
23 July 2014
GSK regularly hosts inspections and we are fully committed to working with regulators to ensure we adhere to the requirements of all Good Manufacturing Practices. Following Health Canada’s most recent planned and regular inspection of our Ste-Foy vaccine manufacturing facility conducted in June 2014, we were assigned a Compliant rating by the agency and are making progress to address their concerns and are committed to working with them to fully resolve all outstanding issues. We are in the process of reviewing their findings and are committed to responding formally by August 4, 2014.
Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients. Every batch of GSK vaccines is subject to extensive review and only product that meets GSK’s rigid quality standards and pass the lot release program from Health Canada are released into the market place. Vaccines that do not pass this rigorous review are discarded.
As noted in Health Canada’s Summary Report, through an amendment to the terms and conditions of our Establishment License proposed by Health Canada on July 8, 2014, the agency now requires 90 days advance notice should we resume production of Fluviral® (DIN 20420686) and FluLaval® Tetra (DIN 02420783) for the Canadian market. We had no objection to the proposed amendment.
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