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
Healthcircle

We're Healthcircle – an award-winning healthcare advertising and creative communications agency, offering a holistic approach to brand health. With a...

Latest intelligence

Empowered patients: shaking the foundations of healthcare
Precision medicine represents a new paradigm in healthcare.This new approach to treating and preventing disease views the patient holistically, analysing their genes, environment and lifestyle, and using this information to...
A uniquely English genomic medicine service
The UK National Health Service is developing one standardised approach to embedding precision medicine across the whole of England. Blue Latitude Health speaks to Dr Tom Fowler, Deputy Chief Scientist...
Blended Intelligence
Data is the most valued commodity of the modern world. For P&P it's all about the application....

Infographics