23 May 2011: The antibiotics manufacturing unit of Hyderabad based, pharmaceutical company has received a warning letter from the US Food and Drug Administration. In this warning letter the USFDA has detailed its observations. As per the field alert report of the Unit III, which reports non-compliance with packaging and labeling norms, the USFDA had ordered the firm to submit a detailed action plan, to rectify the mistake. Aurobindo pharma is given a time period of 15 working days to submit the action plan. The firm had already started preparing the action plan and is requesting the USFDA for the meeting date to submit the final plan.
Previously too, Aurobindo Pharma has received import alert, for detention of unit IV products, in February this year from USFDA, regarding its cephalosporin producing unit IV. This alert came after the US health regulator has done the auditing of unit IV in December 2010.
Source: Economic Times