Dr Reddy’s shares fall over 2% after it gets 4 USFDA observations for Telangana plant
Dr Reddy’s shares ended 2.07% lower at Rs 2138.10 on the BSE.business Updated: Mar 16, 2018 17:13 IST
Drug major Dr Reddy’s Laboratories said on Friday that the US health regulator had issued four observations after inspecting its active pharmaceutical ingredients (API) facility in Telangana.
“The audit of our API Hyderabad plant 1 at Jinnaram Mandal, Medak district, Telangana, by the USFDA has been completed today. We have been issued a Form 483 with four observations which will be addressed comprehensively within stipulated time,” Dr Reddy’s said in a regulatory filing.
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 ended 2.07% lower at Rs 2138.10 on the BSE.