SUNDAY, JULY 22, 2018

FDA warns CSL that it may suspend flu vaccine distribution license

The U.S. Food and Drug Administration sent a warning letter to pharmaceutical giant CSL threatening to suspend its license to distribute flu vaccine in the U.S. if the company does not make changes in its manufacturing practices

The FDA has given the company 15 days to make a reply justifying its stand on the Fluvax vaccine triggering febrile convulsions at 10 times the usual rate last year, News Tonight reports.

The FDA said that an audit team in March found a discernible difference in the manufacturing practices being followed by the company at its Melbourne laboratory.

"The inspection revealed significant violations that included the failure to adequately investigate product and component failures, using components even though they failed to meet specifications and a lack of control over certain tests and procedures,” Sally Burgess, an FDA spokeswoman, said, according to News Tonight.

Australia’s Therapeutic Goods Administration has openly refuted such claims in the letter, including “one of 160 similar letters” issued to drug manufacturers in 2011, according to News Tonight. The FDA may or may not have the evidence needed against CSL and imposing any notice to recall or change a vaccine in the production process may be taken as unjustified, according to News Tonight.