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Aurobindo Pharma gets 6 observations from USFDA for Hyd unit

Press Trust of India  |  New Delhi 

Drug firm Pharma today said the US health regulator has issued six observations for its Unit III formulations facility in

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



"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, 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.

of Pharma were trading at Rs 643.95 per scrip in afternoon trade, down 2.96 per cent from its previous close.

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

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Aurobindo Pharma gets 6 observations from USFDA for Hyd unit

Drug firm Aurobindo Pharma today 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 April 10, 2017 to April 18, 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 ... Drug firm Pharma today said the US health regulator has issued six observations for its Unit III formulations facility in

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

"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, 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.

of Pharma were trading at Rs 643.95 per scrip in afternoon trade, down 2.96 per cent from its previous close.

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

image
Business Standard
177 22

Aurobindo Pharma gets 6 observations from USFDA for Hyd unit

Drug firm Pharma today said the US health regulator has issued six observations for its Unit III formulations facility in

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

"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, 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.

of Pharma were trading at Rs 643.95 per scrip in afternoon trade, down 2.96 per cent from its previous close.

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

image
Business Standard
177 22