FDA Cites GlaxoSmithKline Flu Vaccine Plant for Quality ViolationsJun 25, 2014
The U.S. Food and Drug Administration (FDA) cited a GlaxoSmithKline plant in Canada that makes the flu vaccine Flulaval for failure to meet quality control standards.
The company said it is working to rectify the problems and does not expect a delay in distributing vaccine for the 2014-15 flu season, Reuters reports. Flu vaccine typically starts shipping at the end of July.
The FDA sent GSK a warning letter on June 12, saying the company had failed to take appropriate measures to prevent microbiological contamination of products, but GSK said no contaminated products have been released to the public, according to Reuters. The company says every batch of vaccine is reviewed extensively before release, and "[v]accines that do not pass this rigorous review are discarded."
The FDA letter said the plant’s purified water system has inadequate controls and also that Gram-negative bacteria identified in water used for equipment washing had been implicated in product contamination issues at the facility as far back as 2011, Reuters reports. According to the FDA, the company had no set schedule for disinfection of the water system and manufacturing controls were not adequate to control bacteria on unsterilized surfaces. The agency said the company's investigation into the repeated accumulations of bacteria had been inadequate.
Reuters reports that in 2011, 24 vaccine lots were rejected due to the excessive presence of endotoxins, which can cause health problems in people and animals. Vaccine lots that were rejected in 2012 and 2013 were manufactured on the same equipment as lots for release to the United States, the FDA said in the warning letter. Twenty-one percent of the lots manufactured this year showed bacterial growth and endotoxin levels. GSK said those lots were rejected as part of the company's quality review process.
GSK anticipates providing between 28 and 33 million doses of flu vaccine to the United States for the coming flu season.