Drug factory · FDA FEI 3010868532

Oxalis Labs

Village Theda, P.O. Lodhimajra, Tehsil - Baddi, Solan, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 2, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AcyclovirMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-439
ChlorthalidoneMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-425, 33342-426
CholestyramineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-293
ClobetasolMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-321, 33342-326, 33342-506 +1
EzetimibeMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-373
FluocinonideMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-320, 72603-703
LacosamideMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-302, 33342-303, 33342-304 +1
LidocaineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-405
LurasidoneMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-419, 33342-420, 33342-421 +6
MethimazoleMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-335, 33342-336
NystatinMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-469, 33342-481
Nystatin and Triamcinolone AcetonideMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-482, 33342-483
PerphenazineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-448, 33342-449, 33342-450 +1
RasagilineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-308, 33342-309
RepaglinideMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-248, 33342-249, 33342-250 +3
RifapentineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-599
SevelamerPackages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-288, 33342-289, 72603-398
SildenafilMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-041, 33342-042, 33342-043
SolifenacinMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-148, 33342-149
Triamcinolone AcetonideMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-327, 33342-328, 33342-329 +10

FDA inspection history

EndedResultProgramProblems noted
Jun 2, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 2, 2019Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.