The FDA has sent a scathing warning letter to GlaxoSmithKline's ($GSK) influenza vaccine plant in Quebec City, Canada, that makes FluLaval saying it is not doing near enough to avoid contamination of products there. It said GSK has had ongoing problems with bacteria at the facility and had to reject a fifth of its production just this year.
The warning, issued June 12 and posted on the FDA website Tuesday, said that lapses raised questions about the quality of its FluLaval vaccine and its intermediates. Three responses from GSK since the April inspection, including one June 10, did not do enough to alleviate FDA concerns. The agency recognized GSK's efforts to fix them but said a meeting was needed between the agency and senior management from GSK and its subsidiary ID Biomedical.
"Given the potential contributions of FluLaval to the public health, we encourage frequent interaction between your management and technical staff with FDA to help ID Biomedical and GSK move forward with corrective actions as rapidly as possible," the letter says.
On Tuesday, the company acknowledged the letter in a press release, saying it was working to get issues resolved. It said that, "Pending FDA approvals, GSK anticipates providing between 28 million and 33 million doses of influenza vaccine to the U.S. for the 2014-15 flu season."
The FDA said that of 20 lots manufactured this year, 21% had to be rejected because of bacterial growth and problems with "endotoxin excursions." It also said that in April 2013, contamination was the cause of 80% of rejected eggs. The agency said that there has been problems with the purified water at the plant for years. It said that last year there were 5 alerts for the purified water at the plant because of organisms, including Ralstonia pickettii and Achromobacter xylosoxidans, both of which have been implicated in product contamination that dates back to 2011.
GSK, already the world's largest vaccine maker, in April moved to expand its vax-making capabilities dramatically by agreeing to buy most of Novartis' ($NVS) vaccine operations for $7.1 billion. It, however, didn't pick up Novartis' influenza vaccine business, which the Swiss drugmaker is now trying to sell separately.
This is not the only GSK vaccine plant to run into production issues this year. In January, the U.K.-based drugmaker warned that it was reallocating its 2014 supply of its Varilrix chickenpox vaccine, as well as Priorix-Tetra, a MMRV combo vaccine for measles, mumps, rubella and varicella (chickenpox) because of problems at a plant in Belgium. While the vaccines were not sold in the U.S., they were licensed in 90 other countries.
- here's the GSK release
- read the warning letter