Drug major Dr Reddy's Laboratories has claimed to have received four observations from US health regulator after inspecting its active pharmaceutical ingredients (API) facility in Telangana.
Dr Reddy's in a regulatory filing said, "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.”
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% down at Rs.2145.95 on the BSE.
