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Mar, 17 2018

Dr Reddy's Receives 4 observations from USFDA for Telangana plant

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.

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.

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