Struggles with FDA continue for Lupin as it is handed another Form 483
Troubled generics manufacturer Lupin has struggled with FDA cleaning and process validation guidelines for the past four years. Now, the Indian company’s been hit with another Form 483, following an inspection carried out between March 22 and April 4.
The citation is in regards to violations at the Tarapur, India manufacturing facility. A letter addressed to the National Stock Exchange of India is dated April 5.
“The inspection closed with four observations,” the notice, signed by company secretary RV Satam, says. “We are confident of addressing the observations to the US FDA’s satisfaction. We are committed to adherence and full compliance with cGMP regulations and uphold the highest quality standards across our manufacturing sites.”
Lupin’s familiar with clashes with the FDA. In 2020, the FDA took issue with the Tarapur plant’s conditions. Lupin has been hit with 36 inspection citations since December 2011, the FDA’s online database shows.
Just in July, Lupin subsidiary Novel Laboratories received a warning letter after drug residue was found left on tablet presses and the manufacturing process was not validated after equipment changes, the FDA said in the letter. It was the first violation at that site, but the third in four years for sites within the company’s network.
Two of the company’s sites in India, one in Goa and another in Mandideep, were issued warning letters in 2017 and 2019, respectively, for similar cGMP violations. Those two facilities made products that, at the time, made up more than 40% of Lupin’s sales.
The news comes around the same time that the company received tentative approval from the FDA to market a generic equivalent of Gilead’s Vemlidy, used to treat hepatitis B and HIV infection. That will be made at the company’s Nagpur Facility site in India. It all received approval for its ANDA for generic Pristiq extended-release tablets and launched Merzee capsules in the US all in the last two weeks, as well as acquired a portfolio of brands from Anglo-French Drugs & Industries.
Lupin has 15 manufacturing sites throughout the world, including locations in Brazil, Mexico, Florida and Baltimore.