Lupin is no stranger to FDA rebukes. After facing accusations of “inadequate” manufacturing operations writ large last summer, the generics juggernaut is apparently yet to clean up its act.
Lupin’s active pharmaceutical ingredient (API) plant in Tarapur, India, has been slapped with a Form 483, the company confirmed (PDF) in a filing. The FDA issued its findings after visiting Lupin’s facility between March 22 and April 4, the company said.
The regulator chided Lupin for inadequate manufacturing processes and said the company failed to establish proper cleaning protocols, CNBC first reported.
Further, the company failed to set up in-process samples and controls, and its own investigations into the plant’s deficiencies were lacking, the FDA said in its remarks, as summarized by the news outlet.
“We are confident of addressing the observations to the U.S. FDA's satisfaction,” Lupin said in its filing, adding that it’s “committed to adherence and full compliance with CGMP regulations and uphold[s] the highest quality standards across [its] manufacturing sites.”
This isn’t the Tarapur plant’s first brush with the agency. Back in January 2020, the FDA branded the facility with Official Action Indicated status, meaning “objectionable conditions were found and regulatory action should be recommended,” as the regulator explains online.
In India and elsewhere, Lupin has faced substantial FDA scrutiny in recent years.
Last summer, for instance, Lupin’s Novel Laboratories was handed a laundry list of cleaning, consistency and quality control offenses at its plant in Somerset, New Jersey, despite a previous FDA scolding there in Nov. 2020.
Given parallel infractions by parent company Lupin, the FDA alleged at the time that Lupin’s "corporate oversight and control over the manufacture of drugs is inadequate.” The company needed to take a close eye to manufacturing operations and the meds it produces across all its sites, the regulator said in a warning letter in June.
Lupin's FDA interactions don't stop there. Back in 2017, the company received a warning letter centered on its conditions at two sites in India. That prompted Lupin to commit to improving quality compliance and oversight across its manufacturing network.
Despite those remediation efforts, Lupin continued to find its way into the FDA's crosshairs in 2019 and 2020, when the company received a warning letter and a Form 483 at plants in Mandideep, India, and Andhra Pradesh, respectively.