Drug factory · FDA FEI 3002807511

Lupin Limited

Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep, India

India: 1

Serious problems, FDA action at FDA's last inspection, Nov 23, 2022.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

6 drug inspections on record since 2008: 0 with no problems, 3 with problems fixed voluntarily, 3 with FDA action.

What it does, for whom

DrugRoleForNDC
CefadroxilMakes it Lupin Pharmaceuticals, Inc. 68180-181, 68180-182
CefdinirMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-711, 68180-722, 68180-723
CefiximeMakes it, makes the active ingredient and packages it Lupin Pharmaceuticals, Inc. 68180-405, 68180-407, 68180-416 +1
CefprozilMakes it, makes the active ingredient and packages it Lupin Pharmaceuticals, Inc. 68180-273, 68180-401, 68180-402 +2
CeftriaxoneMakes it and packages it Lupin Limited 57297-611, 57297-622, 57297-633 +1
CephalexinMakes it, makes the active ingredient and packages it Lupin Pharmaceuticals, Inc. 68180-121, 68180-122, 68180-123 +3

FDA inspection history

EndedResultProgramProblems noted
Nov 23, 2022Serious problems, FDA actionDrug Quality Assurance—
Dec 4, 2018Serious problems, FDA actionDrug Quality Assurance—
Feb 19, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 23, 2011Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 30, 2009Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 12, 2008Serious problems, FDA actionDrug Quality Assurance—

Registered with FDA for: api manufacture; manufacture; pack.