After an inspection from March 31 to April 9 of this year, the FDA didn't much like what it saw at GlaxoSmithKline's ($GSK) Ste-Foy plant in Quebec, home of the company's FluLaval influenza vaccines. Now, the agency has issued a warning, pointing its finger at the British drugmaker for not doing its part to avoid contamination.
In a warning letter dated June 12 and posed to the FDA's website Tuesday, the regulator highlighted ongoing bacteria problems that have resulted in GSK tossing more than 20% of the lots it has produced this year alone.
And while Glaxo has already responded three times to the FDA's observations, it hasn't yet done enough to ease its worries, the agency said. Now, it wants a rundown of the additional steps the pharma giant will take to correct its manufacturing issues, as well as a meeting with the company.
"The deficiencies described in the Form FDA 483 issued at the close of the inspection … are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality and purity of your licensed biological drug product and intermediates," the FDA wrote.
GSK, for its part, said in a statement that it's making progress toward addressing the FDA's concerns, and that it's working with the agency to 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," the company said. "Vaccines that do not pass this rigorous review are discarded."
The Canadian facility figures heavily into Glaxo's plans for the upcoming flu season; pending FDA approvals, the company expects to provide between 28 million and 33 million doses of flu vaccine to the U.S., with Ste-Foy responsible for manufacturing FluLaval's portion of that.
- read the warning letter
- see GSK's statement
- read FiercePharmaManufacturing's take
Special Reports: Top 5 Vaccine Companies by Revenue - 2012 - GlaxoSmithKline | Major FDA vaccine approvals of 2012 - FluLaval