USFDA warns Cadila Pharma over drug production processes
New Delhi: The US Food and Drug Administration (FDA) has sent a warning letter to Cadila Pharma over several manufacturing deficiencies at its Gujarat plant.
In a letter issued on October 15, USFDA said inspectors in March had found "significant deviations" from standard manufacturing practices at Cadila Pharmaceuticals' Ankleshwar plant in Gujarat. The US agency also asked Cadila to take measures to rectify the violations, failing which could lead to the ban of exports to the United States from the plant.
Cadila Pharma has been given 15 days to respond to the regulator's query. .
The FDA said a customer complained of an “unpleasant odor” from a specific batch, which an investigation concluded was the result of a “known impurity.” “However, the company failed to implement proposed corrective actions before closing the investigation in 2011,” the agency said.
Several manufacturing plants of leading domestic companies including Ranbaxy, Sun Pharma, Wockhardt and Strides Arcolab have come under the US FDA scanner for compliance related issues. The frequency of regulatory inspections in Indian plants has also increased significantly in past few years.