US FDA seeks voluntary action on Dadra plant in relief for Sun

The US Food and Drug Administration (USFDA) has asked Sun Pharma to take voluntary action at its manufacturing plant in Dadra Nagar Haveli, giving the much needed relief to India's largest drug company that has been under the regulator's scanner again for its manufacturing practices deviations, the regulator’s website said.

The USFDA issued a Voluntary Action Indicated (VAI) letter, which means that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action.

The regulations further state that an inspection classification of VAI will not negatively impact FDA’s assessment of any pending marketing application referencing this facility. Sun Pharma's shares had fallen last week over this development as investors worried about delay in product launches from the company.

In an inspection conducted end-March, the USFDA issued nine observations about the company's deviations from good manufacturing practices. Some of the comments from the FDA were that the employees lacked education and experience required to perform the assigned tasks, no written procedure for production and process control and that drug product samples were not identical to the batches.

Dadra in the union territory of Dadra and Nagar Haveli is the second-largest manufacturing location of Sun Pharma.