The US Food and Drug Administration (FDA) has found fault with multiple Lupin plants in recent years, chastising a finished product site in Goa, India in 2017, and targeting an active pharmaceutical ingredient (API) facility in Mandideep two years later.
In the 2019 warning letter, the US FDA said Lupin’s “repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs are inadequate.” Yet, when asked if Lupin has systemic problems on a recent conference call with investors, managing director Nilesh Gupta refuted the idea.
Gupta said, “I don't see this as a company-wide issue.”
While Gupta acknowledged Lupin needs “to do much better” at addressing quality issues across the company, he also framed the problems faced by his business as part of a bigger issue.
Gupta said, “I think the more projects you see, the more you see that this is an industry issue.”
Whatever the exact nature of the issue, it is affecting Lupin and Gupta wants that to change, telling analysts “we need to get our house in order.”
Lupin piloted a compliance initiative at its site in Indore, India. With that initiative due to wrap up in March, Lupin is now expanding the model to other sites, starting with the facility in Goa that has a history of compliance problems.
Kamal Sharma, vice chairman at Lupin, explained the goals of the initiative.
Sharma said, “The intention really is, especially at a site like Goa and our Somerset site, to work for the next two, three months on some of these remediation efforts so that we feel really good about the status of these sites. I think there's a lot of stuff we've already started, but we want to do a concentrated piece of work for the next three months and then offer them up for re-inspection.”
According to Lupin, the US FDA has agreed to allow it to return to the sites in Goa and Pithampur to assess compliance separately, despite the facilities being covered by a single warning letter. Lupin recently revealed that a US FDA inspection of the Pithampur site led to a Form 483 featuring two observations.