GlaxoSmithKline is in the process of reviewing regulatory results from a June inspection that found that 10 areas of its Ste. Foy, Quebec, vaccine manufacturing plant needed improvements. But in the meantime, Health Canada has imposed a condition on the facility's license, requiring notice before Glaxo resumes production of Fluviral and FluLaval Tetra.
Last month, the FDA chided GlaxoSmithKline over issues at its Canadian flu vaccine plant, home to production of seasonal product FluLaval. Now, it's got another regulator on its case, too: Health Canada wants to see GlaxoSmithKline lay out plans for correcting problems at the facility, and it's giving the company 30 days to do it.
After an inspection from March 31 to April 9 of this year, the FDA didn't much like what it saw at GlaxoSmithKline's 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.
Whereas in the past, a vaccine given in August would offer little protection come February, new formulations are extending the period of immunity. Healthcare professionals have responded by adjusting the advice they give to their patients.