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news.CSL Biotherapies, a division of CSL Limited, has received warning letter from the US Food and Drug Administration (FDA) in connection with its response to FDA's feedback following the inspection of the company's Parkville, Australia site, in March 2011.
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Earlier, following its inspection in March, the FDA issued a list of observed deviations from current Good Manufacturing Practice (GMP).
In return, the company responded to the FDA’s concern addressing the detailed corrected steps taken by the company in response of the FDA’s list.
In the current letter, the FDA has said the provided details from the company are not sufficient enough for the agency to evaluate the adequacy of CSL Biotherapies’ corrective actions.
In its warning letter, the FDA has prominently raised issue in connection with the methodology used by CSL Biotherapies for documenting and managing the processes and investigations at its Parkville facility.
CSL Biotherapies executive vice-president Jeff Davies said their technical team is in the process of preparing more substantive detail about their 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," Davies said.