Aurobindo Pharma gets 6 observations from US FDA for Hyderabad unit

Aurobindo Pharma says the US FDA has issued six observations for its Unit III formulations facility in Hyderabad and all are on procedural improvements


Aurobindo Pharma says none of the US FDA observations are related to data integrity. Photo: Bloomberg
Aurobindo Pharma says none of the US FDA observations are related to data integrity. Photo: Bloomberg

New Delhi: Drug firm Aurobindo Pharma on Wednesday said the US health regulator has issued six observations for its Unit III formulations facility in Hyderabad.

The United States Food and Drug Administration (USFDA) had conducted an inspection at the company's Unit III, a formulations manufacturing facility at Bachupally, Hyderabad from 10 April 2017 to 18 April 2017, Aurobindo Pharma said in a filing to BSE.

"At the end of the inspection, we have been issued a Form 483 with 6 observations. The observations are all on procedural improvements," it added.

None of the observations are related to data integrity, Aurobindo Pharma said.

As per the USFDA, a Form 483 is issued to a company's management at the conclusion of an inspection when "an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts".

It notifies the company's management of objectionable conditions. Shares of Aurobindo Pharma were trading at Rs643.95 per scrip in afternoon trade, down 2.96% from its previous close.

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