Dr. Reddy's gets inspection report from USFDA for Srikakulam-based API plant
The Hindu
USFDA classifies Dr. Reddy's inspection as VAI, with no administrative or regulatory action recommended, shares down 0.42%.
Dr. Reddy's Laboratories on Friday (September 6, 2024) said it has received the establishment inspection report (EIR) from the U.S. health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.
The U.S. 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 U.S. health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility.
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