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FDA warning letter for Aurobindo

India based generics manufacturer, Aurobindo Pharma, has received warning letters from the US Food and Drug Administration calling for changes at two of the company's facilities

India based generics manufacturer, Aurobindo Pharma, has received warning letters from the US Food and Drug Administration (FDA) calling for changes at two of the company's facilities.

In a statement, the company explained that the FDA has requested a 'detailed action plan' for improvements regarding packaging and labelling compliance at unit three of its Hyderabad plant. This was based on a previous field alert report by the agency.

Aurobindo have 15 working days to submit the action plan, with the opportunity to discuss the situation at a regulatory meeting with the FDA.

Aurobindo said it was in the process of responding to these requests.

The FDA also issued an official warning letter following an earlier import alert on Aurobindo's unit six cephalosporin manufacturing plant, which required detention of products from the facility.

23rd May 2011

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