GlaxoSmithKline received a warning from the U.S. Food and Drug Administration about the conditions at its manufacturing facility in Quebec. The FDA said that the plant violated quality requirements during the manufacturing of its influenza vaccine Flulaval.
The FDA sent a letter to the company on June 12 after an inspection of the plant earlier this year. The investigation found that GSK had not established and followed written procedures to prevent microbiological contamination of the manufactured drugs. The report showed that the controls for the purified water system at the facility were not acceptable to prevent contamination.
The FDA requests immediate actions to fix the deviations that may exist in its manufacturing plan. Failure to fix these problems will result in regulatory actions, the warning states. The FDA is requesting a letter from GlaxoSmithKline detailing the steps that the company has taken or will be taking to correct the deviations, within 15 days of the warning.
In 2011, 24 GSK vaccine lots were rejected due to the presence of endotoxins, which are released from the cell walls of Gram-negatives pathogens, such as salmonella, when they die. The company had several lots rejected in March and July 2012 because of contamination. This year, 21 percent of GSK’s lots were rejected due to bacteria growth and the presence of endotoxins. Endotoxins can contaminate lab equipment and can cause health complications in humans and animals.
GlaxoSmithKline has also been in the news recently for paying West Virginia $22 million in a settlement over illegally marketing Avandia, its diabetes medicine. The company also paid for unlawfully marketing Advair, its asthma drug, and two popular antidepressants, paying $105 million to 44 states and the District of Columbia to settle cases.
The attorneys of Lopez McHugh have been involved in major pharmaceutical litigations concerning drugs for over 30 years. If you have suffered significant injuries as result of a company’s negligence or false claims, contact a Lopez McHugh attorney for a free and confidential case evaluation.
