US FDA makes 8 observations after inspecting Lupin’s Aurangabad unit
- Deals Buzz: Bain Capital takes $450 million bridge loan to fund Axis Bank deal
- Skymet raises Series C funding from Germany’s InsuResilience Investment Fund
- Honor Holly 4 Review: Close to Xiaomi Redmi 4, but not better
- Ten Indian films that faced trouble in Pakistan
- Gujarat elections: Results indicate people not happy with BJP, says Shiv Sena
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.