US FDA notes 22 observations at Lupin’s Indian base
The US Food and Drug Administration (FDA) carried out inspections between November 26 and December 4, 2018.
The Mandideep facilities produce active pharmaceutical ingredients (APIs) for its blood pressure drugs, as well as APIs for, and solid oral dosage forms of, cephalosporin – a first line antibiotic.
The company noted, “The inspection at Unit-1, the cephalosporin facilities, closed with 10 observations for the cephalosporin API facilities and eight observations for the cephalosporin Solid Oral Dosage Form facility.
“The inspection at Unit-2, the Cardiovascular ‘Pril’ API facilities, closed with four observations,” the statement continued.
While Lupin suggested the observations were “largely procedural in nature”, the FDA did identify gaps in the aseptic processing areas of the cephalosporin API block.
The company is already working to address the issues, with a ‘Quality Management System and Compliance Sustainability Plan’ underway to address some of the issues raised by the FDA.
A spokesperson for Lupin stated that no further details could be revealed about the inspection outcomes.
During an August inspection this year, the FDA also detected procedural issues at Lupin’s facility in Tarapur, India. The inspection was prompted by valsartan contamination concerns in the EU and US, an issue that is still causing global recalls.
However, Lupin’s facilities were found to pose no risk for ‘sartan’ contamination.
