Dr Reddys gets 5 USFDA observations for Bollaram plant
"The audit of our active pharmaceutical ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad by the United States Food and Drug Administration (USFDA), has been completed today," Dr Reddy's said in a filing to BSE.
NEW DELHI: Dr Reddy's Laboratories (Dr Reddys) said the US health regulator has issued five observations after audit of a company's plant in Hyderabad.
"The audit of our active pharmaceutical ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad by the United States Food and Drug Administration (USFDA), has been completed today," Dr Reddy's said in a filing to BSE.
The company has been issued a Form 483 with 5 observations, it added.
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"We will address them comprehensively within the stipulated timeline," Dr Reddy's said. It however did not provide any details about the observations made by the regulator.
As per the USFDA, Form 483 notifies the company's management of objectionable conditions.
It is issued to the firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
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