Express Pharma

US FDA makes eight observations at Lupin’s Aurangabad unit


The inspection was completed on April 26, 2017

Lupin said the US health regulator has made eight observations after inspecting its Aurangabad facility in Maharashtra.

The facility was recently inspected by the United States Food and Drug Administration (US FDA). The inspection was completed on April 26, 2017, Lupin said in a filing to BSE, “Subsequent to the inspection, the USFDA issued Form 483 citing 8 observations”, it added.

The company is in the midst of putting together a response to address the observations, Lupin said.

As per the USFDA, “a 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 Act and related Acts”.

It notifies the company’s management of objectionable conditions at the facility.

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