Dr Reddy's gets USFDA EIR for Srikakulam API Plant
Sep 06, 2024 16:29
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.
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