FDA hands Lupin VAI inspection report

2023-07-13

The U.S. FDA paid a visit to India-based Lupin Pharmaceuticals — one of the world’s largest generic drugmakers — which resulted in the drugmaker being handed an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification.

VAI classification means that objectionable items were found, but no action is required on the part of the authority and all of the company's actions are on a voluntary basis.

The EIR was issued following a March 21-29, 2023 inspection of Lupin's Pithampur, India manufacturing facility that makes oral solids and ophthalmic dosage forms.

While FDA inspections can result in more serious classifications, given Lupin’s history with the agency’s inspections, a VAI report comes as good news. In a statement, Nilesh Gupta, managing director at Lupin said, “We are pleased to have received the EIR 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.”

Last year, the FDA handed Lupin a Form 483, issuing four observations after inspecting its API plant in Tarapur. Following an inspection, the agency noted that existing procedures and processes for manufacturing APIs were inadequate and the facility had failed to establish and validate its cleaning process.

The year before, in 2021, the agency sent a warning letter to the company’s Novel Laboratories factory in New Jersey. At the time, the agency dinged Lupin for inadequate cleaning procedures of equipment, and in particular, its tablet press. According to the agency, FDA inspectors spotted residue on a tablet press and although Lupin later analyzed the residue, the company failed to test reserve samples of drug products manufactured on the equipment.

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