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regular-article-logo Monday, 23 December 2024

Dr. Reddy's Srikakulam facility gets EIR from USFDA with positive VAI classification after inspection

The US Food and Drug Administration (USFDA) classifies the inspection as Voluntary Action Indicated

PTI New Delhi Published 06.09.24, 04:54 PM
Representational image

Representational image File picture

Dr Reddy's Laboratories on Friday said it 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 Hyderabad-based drug maker said in a statement that the US Food and Drug Administration (USFDA) had classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection was closed.

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As per USFDA, VAI means that objectionable conditions or practices have been found. However, the agency was not prepared to take or recommend any administrative or regulatory action.

On June 7 this year, Dr Reddy's stated that the US health regulator had issued Form 483 with four observations after inspecting its Srikakulam-based facility.

Shares of the company on Friday ended 0.42 percent down at Rs 6,669.75 apiece on the BSE.

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