Dr Reddy’s gets 4 observations from USFDA for Telangana plant
“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 judgement 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 were trading 1.71 per cent down at Rs 2145.95 on the BSE.