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Dr Reddy’s plant under USFDA lens
City-based pharma major Dr Reddy’s Laboratories has received four observations from US health regulator after inspecting its active pharmaceutical ingredients (API) facility in Jinnaram Mandal, Medak district.
Hyderabad: City-based pharma major Dr Reddy’s Laboratories has received four observations from US health regulator after inspecting its active pharmaceutical ingredients (API) facility in Jinnaram Mandal, Medak district.
In a statement, Dr Reddy’s Lab said: “The audit of our API Hyderabad plant-1 in Jinnaram Mandal, Medak district, by the USFDA has been completed. We have been issued a Form 483 with four observations which will be addressed comprehensively within stipulated time.”
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company's management of objectionable conditions. Dr Reddy's shares closed down by Rs 45.10 or 2.07 per cent at Rs 2,138.10 on BSE.
