India: Dr. Reddy's Gets 4 Observations from USFDA for Telangana Plant
Dr. Reddy’s Laboratories has said 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. 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.
According to the USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when investigator has observed any condition that in its judgement may constitute a violation of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company’s management of objectionable conditions.
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