Drug factory · FDA FEI 3005139373

Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.

21B Cotters Ln, East Brunswick, NJ, United States

United States: 1

No problems found at FDA's last inspection, Sep 19, 2023.

No Action Indicated: inspectors found no objectionable conditions.

10 drug inspections on record since 2009: 4 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AcetazolamideMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-287, 23155-288, 23155-787
AcyclovirMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-227, 23155-228, 23155-229
AmantadineMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-362
BenazeprilatMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-749, 23155-750, 23155-751 +1
BenzonatateMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-898, 23155-899
BenzphetamineMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-952
BethanecholMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-934, 23155-935, 23155-936 +1
BumetanideMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Northstar Rx LLC. 23155-900, 23155-901, 23155-902 +3
BupropionMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-191, 23155-192
Calcium CationMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 23155-531, 23155-621, 68382-539 +1
CetirizineLabels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-929
DesmopressinMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-489, 23155-490
DoxazosinMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-092, 23155-093, 23155-094 +1
DoxercalciferolMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-538, 23155-539, 23155-540
EnalaprilatMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-704, 23155-705, 23155-706 +3
EthosuximideMakes it and tests it Zydus Pharmaceuticals (USA) Inc. 68382-443
FluoxetineMakes it, tests it and packages it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-028, 23155-029, 23155-030
HydralazineMakes it, tests it and packages it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-832, 23155-833, 23155-834 +1
HydrochlorothiazideMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-008, 23155-009, 23155-764
HydroxyzineMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Medsource Pharmaceuticals 14539-674, 14539-675, 23155-500 +3
LabetalolMakes it, tests it, packages it and labels it BluePoint Laboratories., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Northstar Rx LLC. 68001-700, 68001-701, 68001-702 +7
LeflunomideMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-043, 23155-044
Lithium CationMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-763
MeclizineMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-943
MethimazoleMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Northstar Rx LLC. 23155-070, 23155-071, 72603-315 +1
NifedipineMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-194, 23155-195
OxybutyninMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-913
ParomomycinMakes it, tests it, packages it and labels it Waylis Therapeutics LLC 80725-250
PrednisoloneLabels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-927
SertralinePackages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-757, 23155-758, 23155-759
TerazosinMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-735, 23155-736, 23155-737 +1
TetracyclineMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-017, 23155-018
TheophyllineMakes it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-741, 23155-742
TrimethobenzamideMakes it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-180
VerapamilMakes it, tests it, packages it and labels it Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-026, 23155-059, 23155-486

FDA inspection history

EndedResultProgramProblems noted
Sep 19, 2023No problems foundDrug Quality Assurance—
Oct 16, 2020No problems foundBioresearch Monitoring—
Feb 6, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 20, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 16, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 8, 2014Problems found, fixed voluntarilyDrug Quality Assurance1
Nov 21, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 28, 2011No problems foundDrug Quality Assurance—
Jul 22, 2010No problems foundDrug Quality Assurance—
Jul 14, 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.

Jan 8, 2014 inspection

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