GSK Statement: FDA Warning Letter - Ste-Foy Manufacturing Facility
24 June 2014
On June 12, 2014, GSK received a Warning Letter from the U.S. Food and Drug Administration (FDA) relating to an inspection the FDA carried out in early April 2014 at our influenza vaccine manufacturing facility in Ste-Foy, Quebec, Canada.
In the letter, the agency raised issues related to certain quality control and manufacturing procedures at the facility. We are making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues.
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 before it is released. Vaccines that do not pass this rigorous review are discarded.
GSK produces influenza vaccines for the U.S. and Canada at the Ste-Foy facility. Pending FDA approvals, GSK anticipates providing between 28 million and 33 million doses of influenza vaccine to the U.S. for the 2014-15 flu season. GSK is also working with Canadian health authorities to meet GSK supply commitments for 2014-15.
While we work with the FDA to fully address its concerns, we also are providing regular updates on our progress to the U.S. Centers for Disease Control and Prevention (CDC), the Public Health Agency of Canada (PHAC) and Health Canada to support their efforts in managing supply of influenza vaccines for the 2014-15 flu season.
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