Drug factory · FDA FEI 3006363714

Macleods Pharmaceuticals Limited

Plot No 25-27, Survey No 366 Premier Industrial Estate Kachigam, Daman, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, May 26, 2023.

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

4 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Amlodipine and Hydrochlorothiazide and OlmesartanMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-243, 33342-244, 33342-245 +2
AtorvastatinMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-315, 33342-316, 33342-317 +1
CandesartanMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-114, 33342-115, 33342-116 +3
Candesartan and HydrochlorothiazideMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-131, 33342-132, 33342-133
CevimelineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-216
ClopidogrelMakes it, tests it, packages it and labels it Northstar Rx LLC. 16714-052
ColchicineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-341
Efavirenz and Emtricitabine and TenofovirMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-138
Emtricitabine and TenofovirMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-106, 16714-534
FebuxostatMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-274, 33342-275
Fenofibric AcidMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-347, 33342-348
Hydrochlorothiazide and IrbesartanMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-057, 33342-058
Hydrochlorothiazide and OlmesartanMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-173, 33342-174, 33342-175 +3
Hydrochlorothiazide and ValsartanMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-074, 33342-075, 33342-076 +2
IrbesartanMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Northstar Rx LLC. 33342-047, 33342-048, 33342-049 +3
LamivudineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-001, 33342-002
Lamivudine and ZidovudineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-003
MilnacipranMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-369, 33342-370, 33342-371 +1
NevirapineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-004
PenciclovirMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-024, 33342-025, 33342-026
PyrazinamideMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-447
QuetiapineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-099, 33342-100, 33342-101 +7
RivastigmineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-089, 33342-090, 33342-091 +1
SevelamerMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-215, 33342-241, 33342-242
SilodosinMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-384, 33342-385
TadalafilMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-265, 33342-266, 33342-267 +2
TenofovirMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-096
ValsartanMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-062, 33342-063, 33342-064 +1
VardenafilMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited, Qyk Brands LLC 33342-151, 33342-152, 33342-153 +6
VareniclineMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-489, 33342-490, 33342-577
ZiprasidoneMakes it, tests it, packages it and labels it Macleods Pharmaceuticals Limited 33342-144, 33342-145, 33342-146 +1

FDA inspection history

EndedResultProgramProblems noted
May 26, 2023Problems found, fixed voluntarilyDrug Quality Assurance1
May 29, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 15, 2013No problems foundDrug Quality Assurance—
Feb 24, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 26, 2023 inspection

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