Source – Lupin
Lupin, a major generics company, has received a relatively mild rebuke from the US Food and Drug Administration (FDA) following an inspection of its Pithampur Unit-2 manufacturing facility in India. The FDA classified the inspection report as Voluntary Action Indicated (VAI), which indicates the discovery of “objectionable conditions or practices” but does not require immediate regulatory action. Lupin has the option to voluntarily address any deficiencies identified during the inspection.
Lupin did not disclose the specific deficiencies found at the Pithampur plant, which manufactures oral solids and ophthalmic dosage forms. Despite this, the company expressed satisfaction with the inspection outcome in a press release.
Lupin operates 15 manufacturing sites, seven research centers, and employs over 20,000 staff members globally. However, the company has faced FDA scrutiny in recent months. Last November, Lupin received a Form 483 at its active pharmaceutical ingredients (API) plant in Mandideep, marking the fourth regulatory reprimand from the FDA within nine weeks targeting different sites in India. Prior to the Mandideep incident, Lupin disclosed five violations following an FDA review of its injectables manufacturing site in Nagpur, and 18 compliance problems at its biosimilars plant in Pune.
“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. 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 product approvals and launches, especially ophthalmic products from this facility now.”
– Lupin’s managing director, Nilesh Gupta, said in a statement posted on the Bombay Stock Exchange
While Lupin’s latest inspection report could have been worse, the company’s history with FDA rebukes highlights ongoing regulatory challenges it faces in ensuring compliance across its manufacturing facilities.
Also in November, Lupin revealed that it had suspended production of US 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.