Drug factory · FDA FEI 1000115322

Sixarp, LLC

7650 Caterpillar CT SW D, Grand Rapids, MI, United States

United States: 1

No problems found at FDA's last inspection, Mar 6, 2025.

No Action Indicated: inspectors found no objectionable conditions.

4 drug inspections on record since 2010: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AlbuterolMakes it, packages it and labels it Praxis, LLC 59368-401, 59368-412
ButorphanolMakes it, packages it and labels it Praxis, LLC 59368-400
DabigatranPackages it and labels it Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0108, 0597-0355, 0597-0360 +6
Empagliflozin and LinagliptinPackages it and labels it Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0164, 0597-0182
EstradiolMakes it, packages it and labels it Bayer HealthCare Pharmaceuticals Inc., Praxis, LLC 50419-451, 50419-452, 50419-453 +9
Estradiol and LevonorgestrelPackages it Bayer HealthCare Pharmaceuticals Inc. 50419-491
Hydrochlorothiazide and TelmisartanPackages it and labels it Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0042, 0597-0043, 0597-0044
IbuprofenMakes it, packages it and labels it Praxis, LLC 59368-402
LinagliptinPackages it and labels it Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0140
Linagliptin and MetforminPackages it and labels it Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0146, 0597-0147, 0597-0148
LisinoprilMakes it, packages it and labels it Praxis, LLC 59368-406
Mycophenolic AcidMakes it, packages it and labels it Praxis, LLC 59368-403
TamsulosinPackages it and labels it Sanofi-Aventis U.S. LLC 0024-5837
TopiramateMakes it, packages it and labels it Praxis, LLC 59368-405
TriptorelinMakes it, packages it and labels it Praxis, LLC 59368-404
ZonisamideMakes it, packages it and labels it Praxis, LLC 59368-407

FDA inspection history

EndedResultProgramProblems noted
Mar 6, 2025No problems foundDrug Quality Assurance—
Feb 5, 2019No problems foundDrug Quality Assurance—
Apr 25, 2014No problems foundDrug Quality Assurance—
May 28, 2010Problems found, fixed voluntarilyDrug Quality Assurance2

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 28, 2010 inspection

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