US FDA makes 8 observations after inspecting Lupin’s Aurangabad unit
Lupin’s Aurangabad facility was recently inspected by the US FDA, following which the issued Form 483, citing 8 observations
New Delhi: Pharmaceutical company Lupin Ltd on Tuesday said the US health regulator has made eight observations after inspecting its Aurangabad facility in Maharashtra.
The facility was recently inspected by the US Food and Drug Administration (US FDA). The inspection was completed on 26 April, 2017, Lupin said in a filing to BSE. “Subsequent to the inspection, the US FDA 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 US FDA, “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. The Lupin stock closed at Rs1,250.70, down 2.25 per cent, on BSE.