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USFDA issues warning letter to Aurobindo Pharma

The US Food & Drug Administration (USFDA) has issued a warning letter to India-based drug-maker Aurobindo Pharma, with regard to its antibiotics manufacturing unit in Hyderabad, detailing their observations.

Aurobindo said the health regulator, based on a field alert report related to non-compliance with packaging and labelling norms at Unit III of the facility, has asked the company to submit a detailed action plan on rectifying the situation.

Aurobindo Pharma is required to submit the action plan to the USFDA within 15 working days and has also been given an opportunity for a regulatory meeting with the USFDA.

The company had earlier received an import alert in February this year from USFDA for its cephalosporin-producing Unit VI located at Chitkul Village, in Hyderabad.