Home / United States / Sixarp, LLC
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
Drug Role For NDC
Albuterol Makes it, packages it and labels it
Praxis, LLC
59368-401 , 59368-412
Butorphanol Makes it, packages it and labels it
Praxis, LLC
59368-400
Dabigatran Packages it and labels it
Boehringer Ingelheim Pharmaceuticals, Inc.
0597-0108 , 0597-0355 , 0597-0360 +6
Empagliflozin and Linagliptin Packages it and labels it
Boehringer Ingelheim Pharmaceuticals, Inc.
0597-0164 , 0597-0182
Estradiol Makes it, packages it and labels it
Bayer HealthCare Pharmaceuticals Inc. , Praxis, LLC
50419-451 , 50419-452 , 50419-453 +9
Estradiol and Levonorgestrel Packages it
Bayer HealthCare Pharmaceuticals Inc.
50419-491
Hydrochlorothiazide and Telmisartan Packages it and labels it
Boehringer Ingelheim Pharmaceuticals, Inc.
0597-0042 , 0597-0043 , 0597-0044
Ibuprofen Makes it, packages it and labels it
Praxis, LLC
59368-402
Linagliptin Packages it and labels it
Boehringer Ingelheim Pharmaceuticals, Inc.
0597-0140
Linagliptin and Metformin Packages it and labels it
Boehringer Ingelheim Pharmaceuticals, Inc.
0597-0146 , 0597-0147 , 0597-0148
Lisinopril Makes it, packages it and labels it
Praxis, LLC
59368-406
Mycophenolic Acid Makes it, packages it and labels it
Praxis, LLC
59368-403
Tamsulosin Packages it and labels it
Sanofi-Aventis U.S. LLC
0024-5837
Topiramate Makes it, packages it and labels it
Praxis, LLC
59368-405
Triptorelin Makes it, packages it and labels it
Praxis, LLC
59368-404
Zonisamide Makes it, packages it and labels it
Praxis, LLC
59368-407
FDA inspection history
Ended Result Program Problems noted
Mar 6, 2025 No problems found Drug Quality Assurance — Feb 5, 2019 No problems found Drug Quality Assurance — Apr 25, 2014 No problems found Drug Quality Assurance — May 28, 2010 Problems found, fixed voluntarily Drug Quality Assurance 2
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
Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12) Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.Procedures not in writing, fully followed 21 CFR 211.22(d) The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: label; manufacture; pack; relabel; repack.