Lupin is no stranger to FDA rebukes, though its latest write-up from the U.S. drug regulator certainly could have been worse for the company.
Following an inspection of Lupin’s Pithampur Unit-2 manufacturing facility in Madhya Pradesh, India, from March 21 to March 29, 2023, the FDA handed the company an inspection report with a classification of Voluntary Action Indicated (VAI).
Inspection reports are classified one of three ways: No Action Indicated; Voluntary Action Indicated; or Official Action Indicated, with the latter classification the most severe.
In Lupin’s case, the receipt of a VAI tag means the FDA uncovered “objectionable conditions or practices” during its review of the company’s facility, but it stopped short of taking or recommending administrative or regulatory action. Any remediation efforts Lupin may pursue are voluntary on the part of the company.
Lupin did not clarify what sort of deficiencies the FDA uncovered at its Pithampur plant, which produces oral solids and ophthalmic dosage forms. Overall, the company is satisfied with the outcome of the inspection, the company said in a release.
“We are pleased to have received the [Establishment Inspection Report] from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility,” Lupin’s managing director, Nilesh Gupta, said in a statement posted on the Bombay Stock Exchange. “This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance. We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” he added.
All told, generics major Lupin operates 15 manufacturing sites, seven research centers and employs more than 20,000 staffers worldwide.
In recent months, however, the company has run afoul of the FDA on multiple occasions.
Last November, Lupin said it had been hit with a Form 483 at its active pharmaceutical ingredients (API) plant in Mandideep. While the disclosure was light on details, the regulatory reprimand marked the fourth the company had received from the FDA in the past nine weeks—each targeting a different site in India.
Prior to the Mandideep write-up, Lupin disclosed five violations on the heels of an FDA review of its injectables manufacturing site in Nagpur, which was preceded by a whopping 18 compliance problems found at its biosimilars plant in Pune.
Also in November, Lupin revealed that it had suspended production of U.S.-bound drugs from a troubled drug ingredients plant in Tarapur, where the FDA asked the company to provide notification “before resuming operations.” Lupin first acknowledged problems at the facility in September, when it noted the receipt of an FDA warning letter but did not indicate that it had halted production.