USFDA warns Aurobindo pharma

US health regulator sends a warning letter to Drug-maker Aurobindo Pharma with regard to its antibiotics manufacturing unit in Hyderabad. They earlier received an import alert from the US Food and Drug Administration (USFDA) for its cephalosporin-producing Unit VI located at Chitkul Village, in Hyderabad, Andhra Pradesh. The USFDA has asked Aurobindo Pharma to submit a detailed action plan on rectifying the situation, based on a field alert report related to non-compliance with packaging and labeling norms at Unit III of the facility. The action plan is to be submitted to the USFDA within 15 working days as the company has been given an opportunity for a regulatory meeting with the USFDA at their office. Audit of unit VI of the Hyderabad based firm was done by USFDA in the month of December, 2010. Subsequent to the audit findings, the USFDA had imposed an import alert for detention of Unit VI products. The shares of Aurobindo Pharma ended at Rs 175.55 apiece on the Bombay Stock Exchange, down 9.23 per cent from their previous close.

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