Drug factory · FDA FEI 3002808385

Taro Pharmaceutical Industries Ltd.

14 Hakitor Street, Haifa Bay, Israel

Israel: 1

No problems found at FDA's last inspection, Dec 8, 2022.

No Action Indicated: inspectors found no objectionable conditions.

7 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Acetaminophen and Butalbital and CaffeineMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4222
AmcinonideMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4054, 51672-4060
AmiodaroneMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4025, 51672-4055, 51672-4056 +1
Anhydrous Citric Acid and Urea C-13Makes it Meridian Bioscience Israel Ltd 50402-100
AzithromycinMakes it Taro Pharmaceuticals U.S.A., Inc. 51672-4200
BetamethasoneMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4188
Betamethasone and ClotrimazoleMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4048
Brompheniramine and Dextromethorphan and PseudoephedrineMakes it Taro Pharmaceuticals U.S.A., Inc. 51672-4165
BumetanideMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4223, 51672-4224, 51672-4225
CarbamazepineMakes it and makes the active ingredient Caraco Pharmaceutical Laboratories, Ltd. 51672-4005, 51672-4041, 51672-4047 +4
CetirizineMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4070
ClindamycinMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4081, 51672-4194
ClobazamMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4227
ClobetasolMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-1258, 51672-1259, 51672-4193
ClocortoloneMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4166
ClomipramineMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4011, 51672-4012, 51672-4013
Clorazepic AcidMakes it Caraco Pharmaceutical Laboratories, Ltd., Northstar Rx LLC. 51672-4042, 51672-4043, 51672-4044 +3
DapsoneMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4197, 51672-4198
DeferiproneMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4196, 51672-4237
DesonideMakes it and tests it Caraco Pharmaceutical Laboratories, Ltd., Northstar Rx LLC. 51672-1280, 51672-1281, 51672-4079 +1
DiclofenacMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4240
DoxepinMakes it Caraco Pharmaceutical Laboratories, Ltd., Northstar Rx LLC., Taro Pharmaceuticals U.S.A., Inc. 51672-4246, 51672-4247, 16714-132 +9
EnalaprilatMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4037, 51672-4038, 51672-4039 +2
Enalaprilat and HydrochlorothiazideMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4045, 51672-4046
EtodolacMakes it Caraco Pharmaceutical Laboratories, Ltd., Northstar Rx LLC. 51672-4016, 51672-4017, 51672-4018 +7
FelbamateMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4172, 51672-4185, 51672-4186
FluocinonideMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-1273
FluorouracilMakes it Caraco Pharmaceutical Laboratories, Ltd., Northstar Rx LLC. 51672-4062, 51672-4063, 51672-4118 +1
FluphenazineMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4233, 51672-4234, 51672-4235 +1
HydrocortisoneMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-1290, 51672-1292, 51672-4061 +2
ImiquimodMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4145, 51672-4174
KetoconazoleMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4026
LactuloseMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4243
LamotrigineMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4130, 51672-4131, 51672-4132 +5
LevetiracetamMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4136, 51672-4137, 51672-4141 +2
Magnesium Cation and Sodium Sulfate and Sulfate IonMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4170
MeprobamateMakes it Taro Pharmaceuticals U.S.A., Inc. 51672-4147, 51672-4148
MetronidazoleMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4116, 51672-4164, 51672-4215
MupirocinMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-1312
NortriptylineMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4001, 51672-4002, 51672-4003 +1
NystatinMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-1289
Nystatin and Triamcinolone AcetonideMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-1263
PerampanelMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4204, 51672-4205, 51672-4206 +4
PhenytoinMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4069, 51672-4111, 51672-4146
RivaroxabanMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-4228
Triamcinolone AcetonideMakes it Caraco Pharmaceutical Laboratories, Ltd. 51672-1282
WarfarinMakes it Caraco Pharmaceutical Laboratories, Ltd., Golden State Medical Supply, Inc. 51672-4027, 51672-4028, 51672-4029 +15

FDA inspection history

EndedResultProgramProblems noted
Dec 8, 2022No problems foundDrug Quality Assurance—
Jul 11, 2019Problems found, fixed voluntarilyDrug Quality Assurance1
Feb 5, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
May 21, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 6, 2012No problems foundDrug Quality Assurance—
May 28, 2010Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 10, 2009Problems 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.

Jul 11, 2019 inspection

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