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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

BS Reporter  |  Hyderabad 

Dr Reddy's laboratory
Dr Reddy's laboratory

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

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 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 plant, after its inspection teams found compliance issues.

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

is the name given by the 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.

First Published: Tue, November 21 2017. 17:57 IST
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