Lupin's Dabhasa unit in Gujarat pulled up by USFDA for minor violations - Firstpost
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Lupin's Dabhasa unit in Gujarat pulled up by USFDA for minor violations

#dabhasa unit   #form 483   #Lupin   #USFDA  


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New Delhi: Drug firm Lupin Friday said US health regulator has voiced minor concerns after completing the inspection of its Dabhasa facility in Gujarat.

Reuters

Reuters

"United States Food and Drug Administration (USFDA) inspected its (the company's) Dabhasa facility from 29th June to 6th July 2016. At the end of the inspection, two 483s were issued," Lupin said in a filing to BSE.

Both the observations are minor in nature and corrective and preventive actions were shown to the inspectors during the inspection, it added.

As per the USFDA, the purpose of a "Form 483 is to notify the company's management of objectionable conditions".

An FDA Form 483 is issued to firm management at the conclusion of an inspection "when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."

The inspection has been classified as Voluntary Action Indicated, Lupin said.

First Published On : Jul 8, 2016 18:22 IST

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