Dr Reddy's gets USFDA EIR for Srikakulam API Plant
Dr Reddy's Laboratories received a Voluntary Action Indicated (VAI) establishment inspection report (EIR) from the USFDA for its API facility in Srikakulam, Andhra Pradesh.
New Delhi, Sep 6 (PTI) Dr Reddy's Laboratories on Friday said it has received the establishment inspection report (EIR) from the US health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.
The US Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement.
As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
On June 7 this year, Dr Reddy's had stated that the US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility.
Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE.
The US Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement.
As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
On June 7 this year, Dr Reddy's had stated that the US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility.
Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE.
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