The letter details a number of ‘significant objectionable conditions’ observed during an inspection earlier this month, several of which related to the scope of CSL’s investigation of ‘black particles’ detected in vaccines produced at the plant.
Specifically, the US regulator said CSL failed to evaluate an interaction between the vaccine and its packaging that was identified as a potential root cause of the problem by a supplier several years ago.
“Your firm was notified by its stopper supplier on December 17, 2009, that rubber stoppers may react with thimerosal and therefore are not recommended for use with thimerosal containing products. To date your firm still utilizes these stoppers for MDV’s of vaccine containing thimerosal.”
The Food and Drug Administration (FDA) also criticises CSL for failing to conduct extractability and leachability studies on stopper and vial components used to produces several batches of its Afluria and H1N1 vaccines.
Australia’s Therapeutic Goods Administration (TGA) responded to the letter, explaining that it is aware of the issues raised by the FDA.
“The TGA audits CSL annually and, in addition, has undertaken five separate audits of CSL in the last 12 months following a higher than average rate of adverse reactions in children immunised with CSL's flu vaccine 'Fluvax' in 2010.
“Neither the TGA nor the FDA have identified manufacturing deficiencies that would warrant product recall or a change to the vaccine production process.
CSL VP Jeff Davies told the Wall Street Journal that the firm “is committed to the highest standards of compliance in our quality systems and we are taking the warning letter very seriously.
“Our technical team is in the process of preparing more substantive details about our corrective actions to meet the FDA's requirements.''
Lawsuit
Publication of the FDA letter follows just days after Australian couple, Mick and Kirsten Button, launched a legal action against CSL alleging that their infant daughter was disabled after receiving the firm’s influenza vaccine in April.
According to Australia’s ABC News Button family's lawyer Julian Johnson alleges that the flu vaccine manufactured by CSL was defective within the terms of the country’s Trade Practices Act.
He also said that: “There will be claims against the State Government in relation to their administration of the flu vaccine program last year, which will run as part of the same court case as the action against CSL.”