483 Impedes U.S. Expansion for India’s Second-Largest Drugmaker

Lupin’s plans to expand its sales in the U.S. market have been delayed as the result of Form 483 citations at its facility in Goa, India.

The 483 cites nine observations at the Lupin facility, including three involving facilities and equipment systems, three on the production system, and one each on laboratory control systems, quality systems, and the materials system. The issues are considered minor, which is why the company did not receive a warning letter, Lupin said.

Lupin has been sending the FDA responses to the issues over the last few months, but plans to send the FDA its complete response in December and believes the facility will be cleared in early 2017.