Lupin gets EIR with voluntary action indicated from FDA for Goa facility

Lupin Limited said that it has been issued the establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its manufacturing facility in Goa following an inspection in September 2021.

The US FDA determined that the inspection classification of the Goa manufacturing facility is voluntary action indicated (VAI).

Voluntary Action Indicated means objectionable conditions or practices were identified but the FDA is not prepared to either take or recommend any administrative or regulatory action.

Vinita Gupta — CEO of Lupin said: “We are very happy to have received the EIR from US FDA with Voluntary Action Indicated classification for our Goa plant. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance.

“We are committed to manufacture and supply products of the highest quality from all our manufacturing sites.”

According to Lupin’s Managing Director Nilesh Gupta, the EIR with voluntary action indicated is a highly positive development for the company.

He further said that the Goa manufacturing facility of Lupin has a very important place in the US market.

Nilesh Gupta said: “We remain committed to meet and exceed global standards of quality and compliance at all our manufacturing facilities globally.”

Recently, Lupin launched its diagnostics business in India — Lupin Diagnostics as part of its bid to offer integrated healthcare in India.