UPDATE 2-U.S. FDA cites GSK flu vaccine plant for quality violations

Tue Jun 24, 2014 12:39pm EDT
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(Adds details from FDA warning letter, GSK comment)

By Toni Clarke

WASHINGTON, June 24 (Reuters) - A GlaxoSmithKline Plc plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards.

GSK said it is working to rectify the problems and does not expect a delay in distributing the vaccine for the 2014-2015 flu season. The company typically starts shipping the product at the end of July.

In a warning letter dated June 12 to GSK's flu vaccine manufacturing facility in Ste-Foy, Quebec, the FDA said the company failed to take appropriate steps to prevent microbiological contamination of products, among other violations.

GSK said on Tuesday no contaminated products had been released to the public.

"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 FDA said controls for the purified water system at the plant were inadequate and that some 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. (1.usa.gov/1jL3UUS).

In 2011, 24 vaccine lots were rejected due to the excessive presence of endotoxins. These are found in the cell walls of Gram-negative pathogens such as salmonella. When bacteria die the endotoxins are released, possibly contaminating laboratory equipment and causing health problems in people and animals.   Continued...