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.

The TGA said in a statement it had inspected CSL’s vaccine manufacturing and quality assurances processes five times since May last year.

“These audits revealed similar issues to those found by the FDA – the only difference with the FDA is that they publish the outcomes of the audits on their website,” a TGA spokesperson said.

The outcomes of the TGA transparency review were due shortly, and this would propose “more transparency initiatives to be undertaken by the TGA”.

Dr Jeff Davies, executive vice-president of CSL Biotherapies, said the company was taking the FDA’s warning letter very seriously.

“Our technical team is in the process of preparing more substantive detail about our corrective actions to meet the FDA’s requirements,” Dr ­Davies said.