Dr Reddy's requests USFDA for re-inspection of Duvvada facility in 2018

In November 2015, the USFDA had issued warning letter against 3 of Dr Reddy's facilities, including the Duvvada plant, after its inspection teams found compliance issues

Dr Reddy's Laboratories Limited on Wednesday informed the stock exchanges that the company has received the establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for its formulations manufacturing facility at Duvvada in Visakhapatnam.

But the company was told that the inspection process was not over yet.

"In the cover letter to the EIR, FDA has explained that the inspection has not closed, and the site's status remains unchanged, but that FDA has released the EIR in order to be transparent about its regulatory process. We are planning to request a reinspection in 2018 after further discussion on scheduling with FDA," Dr Reddy's said in a filing.

It may be recalled that in November 2015, the US drug regulator had issued a warning letter against three of Dr Reddy's facilities, including the Duvvada plant, after its inspection teams found compliance issues.

Commenting on the development, Sarabjit Kour Nangra of Angel Broking said, as far as financials are concerned, the event would not change the status of the company, as EIR is just an observation note and doesn't equate to the company getting a clean chit from the USFDA.

EIR is the name given by the USFDA for an entire narration of what the FDA investigator/ inspector did during the time spent at the establishment (facility), from the stage of introductions till the hand-over of the inspectional observations.