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Dr Reddys gets Establishment Inspection Report from USFDA for Bollaram facility

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Dr Reddys gets Establishment Inspection Report from USFDA for Bollaram facility

New Delhi: Hyderabad-based drug major, Dr Reddy’s Laboratories has received an Establishment Inspection Report (EIR) from the US Health regulator for company’s active pharmaceutical ingredients (API) manufacturing plant at Bollaram, Telangana.

The US Food and Drug Administration (USFDA) has classified inspection of Bollaram facility as Voluntary Action Initiated (VAI).

“..with regard to the audit of our API manufacturing plant 2 at Bollaram, Hyderabad, we would like to inform you that we have received the Establishment Inspection Report (EIR) from US FDA, for the above-referred facility, indicating closure of the audit and the inspection classification of this facility is determined as Voluntary Action Initiated (VAI),” Dr Reddy’s said in a filing.

Prior to this, USFDA had issued Form 483 with 5 observations for the Bollaram facility. Form 483 is issued to the firm’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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Dr Reddys was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India.

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Also Read: Dr Reddys gets 5 USFDA observations for Bollaram plant


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