CSL Trying to Resolve FDA Concerns

CSL Trying to Resolve FDA Concerns

September 29th, 2011 // 12:52 pm @

Pharmaceutical company CSL says it has addressed the majority of manufacturing flaws highlighted by FDA and remaining concerns are currently being resolved.

Audits carried out by the FDA in 2010 and 2011 revealed “objectionable conditions and practices” within CSL, News Ltd reported on Thursday.

Allegations include the failure of laboratory staff to wear masks while dispensing and mixing vaccines and “deficient” tests to check whether viruses were properly split to prevent side-effects.

CSL on Thursday said the FDA’s inspection reports contained observations only, and were not final determinations on a manufacturer’s compliance with regulations.

CSL added that it had not received any new letters or warnings from the FDA, or Australian regulators, since June.

The issues contained in June’s warning letter were in the process of resolution, while the concerns raised in the FDA’s April 2010 report had been addressed to the FDA’s satisfaction, CSL said.

Many of the concerns raised in the FDA’s report in March this year had also been satisfactorily addressed, it said.

Issues requiring further attention were highlighted in an FDA warning letter issued in June, and CSL was working with the FDA and the Therapeutic Goods Administration (TGA) to resolve those concerns, the company said.

“CSL Biotherapies takes the safety and quality of its medicines very seriously and is fully committed to resolving all outstanding cGMP (current Good Manufacturing Practice) issues to the full satisfaction of the FDA and the TGA as quickly as possible,” it said in a statement.

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