Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Life Healthcare Communications

Life is a creative communications agency offering multi-channel solutions for the healthcare industry. We use a storytelling approach to turn...

Latest intelligence

No Voice, No Choice
Adelphi Research UK’s insights help to campaign for change in the Mental Health Act...
Island
Pharma’s isolated islands of innovation
With service design and technology often failing the patient, why perspective on improving outcomes need to change...
Uncertainty, austerity and Brexit
What does it mean for the life science sector?...

Infographics