CSL’s quality assurance under more scrutiny
THE TGA has “issues” with vaccine manufacturer CSL’s quality assurance process in line with concerns raised by the US Food and Drug Administration (FDA) which now threaten the company’s access to the American market.
A warning letter to CSL posted on the FDA’s website gives the company until 30 June to make changes to its operations or potentially lose its licence to sell vaccines into the US – a market worth $53 million in 2010.
CSL had deviated from good manufacturing practice and “failed to thoroughly investigate” FDA concerns, the regulator said.
It pointed to gaps in documentation and testing as well as “limited analysis” of the spike in febrile convulsions and adverse reactions in children administered Fluvax in early 2010.
CSL had not properly compared virus inactivation and virus splitting for 2010 lots with previous seasons’ lots, the FDA said.