A fourth Lupin manufacturing facility in India has been flagged for violations, the company revealed in a Thanksgiving Day regulatory filing.
The FDA has slapped (PDF) Lupin with another Form 483 notice, citing eight violations at its active pharmaceutical ingredients (API) plant in Mandideep. The notification came after the U.S. regulator inspected the plant from Nov. 14 to Nov. 23.
The 36-year-old facility is one of the largest of Lupin’s 12 sites in India, employing 1,150 people.
“We are committed to addressing the observations and will work with the U.S. FDA to resolve these issues at the earliest,” Lupin wrote in its Nov. 24 filing with the Bombay Stock Exchange and the National Stock Exchange of India. “We do not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility.”
It was another cut-and-paste message from the company which has revealed four compliance reprimands from the FDA over the last nine weeks—each for a different site in India.
In late October, Lupin said its injectables manufacturing site in Nagpur was flagged for five violations. Also in October, the company’s biosimilars plant in Pune was slammed (PDF) for 18 compliance problems.
The most serious sanction from the FDA came when it shut down production of products bound for the United States at Lupin’s API plant in Tarapur. The action came after Lupin failed to resolve issues at the plant first identified in an inspection from March 22 to April 4 of this year.