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  1. DRL gets 5 observations from USFDA for Bollaram facility

DRL gets 5 observations from USFDA for Bollaram facility

The US Food and Drug Administration (US FDA) has issued a Form 483 with five observations to an active pharmaceutical ingredient (API) facility of Dr Reddy’s Laboratories.

By: | Hyderabad | Published: March 10, 2018 2:40 AM
DRL, USFDA, bollaram facility, pharmaceutical, Dr Reddys Laboratories The US Food and Drug Administration (US FDA) has issued a Form 483 with five observations to an active pharmaceutical ingredient (API) facility of Dr Reddy’s Laboratories.

The US Food and Drug Administration (US FDA) has issued a Form 483 with five observations to an active pharmaceutical ingredient (API) facility of Dr Reddy’s Laboratories. A Form 483 is issued to a company at the conclusion of an inspection, when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In a filing to the BSE, the company said plant-3 at Bollaram, on the outskirts of Hyderabad, has received these observations upon completion of an inspection. “These observations are related to procedures and facility maintenance. We will address them comprehensively within the stipulated time,” Dr Reddy’s said in its filing.

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