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.
Shares of the company on Friday ended 0.42% down at ₹6,669.75 apiece on the BSE.
Published - September 06, 2024 11:03 pm IST
