New Delhi: Drug major Dr Reddy’s Laboratories said 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 the 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 the 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.