CSL receives official warning from FDA

Australia’s largest biotech, CSL, last week received an official warning from the US Food and Drug Administration listing concerns relating to the company’s manufacture of its influenza vaccine, Afluria, at its Parkville, Victoria, plant

The FDA conducted inspections in March this year and found a number of “significant objectionable conditions relating to [CLS’s] facility’s compliance with CGMP”, or ‘current good manufacturing practice.’

Many of the concerns surround methodology and documentation of investigations into batches of vaccine that failed to meet specifications.

These investigations come in the wake of the ‘Adverse Events’ that followed vaccination of children, resulting in fevers and convulsions, in April last year.

The letter, from Mary Malarkey, Director of the Office of Compliance and Biologics Quality, accuses CSL of undertaking insufficient analysis of manufacturing processes to determine the cause of the increase in Adverse Events.

“There was no analysis of all critical parameters and critical processing steps to try to determine differences in the 2010 lots associated with Adverse Event reports compared to lots from previous seasons,” said the letter.

CSL had already responded to the FDA with the results of its investigations, but the FDA found that response to be insufficient. “We believe that your response did not provide sufficient detail to fully assess the adequacy of your corrective actions,” it said.

The letter stresses that CSL need tackle these concerns immediately. “You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions may include license suspension and/or revocation.”

In response to the letter, CSL Executive Vice-President, Dr Jeff Davies, responded that CSL intends to address the FDA’s concerns immediately.

“CSL Biotherapies is committed to the highest standards of compliance in our quality systems and we are taking the Warning Letter very seriously,” he said. “Our technical team is in the process of preparing more substantive detail about our corrective actions to meet the FDA's requirements.

“We will work diligently with the FDA to resolve these GMP issues as quickly as possible while continuing to fulfil our commitments to public health programs in Australia and internationally,” said Dr Davies.

CSL (ASX:CSL) stocks were down 12c to $32.14 in morning trading.