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Dr Reddy's gets 5 observations for its API plant at Medak

Press Trust of India  |  New Delhi 

Drug firm today said it has received five observations from the US health regulator for its plant at in The audit of the company's Hyderabad plant 3 at district by the and (USFDA) has been completed today, said in a filing to BSE. "We have been issued a Form 483 with five observations," it added. The observations are related to procedures and facilities maintenance, Dr Reddy's said.

It however did not give specific details about the observations. "We will address them comprehensively within stipulated time," it added. As per the USFDA, an Form 483 is issued to a firm's management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Drug and Cosmetic Act and related Acts. It notifies the company's management of objectionable conditions at the facility. Dr Reddy's stock closed 0.70 per cent down at Rs 2130.45 on BSE.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, March 09 2018. 19:30 IST
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