Indian pharmaceutical company Aurobindo Pharma has received a warning letter from the US Food and Drug Administration relating to its antibiotics manufacturing plant in Hyderabad.

The company received an import alert in February concerning the plant responsible for the production of cephalosporin, and the FDA has now requested that Aurobindo submit a detailed action plan on rectifying the situation.

The warning relates to non-compliance with packaging and labelling norms based on findings from a field alert report, and the action plan must be submitted within 15 working days although the FDA will allow a regulatory meeting to take place.

A statement from Aurobindo said, “The company is requesting USFDA for the meeting date and is in the process of submitting a detailed action plan.”