Drug factory · FDA FEI 3002806556
Boehringer Ingelheim Pharma GmbH and Co. KG
Binger Strasse 173, Ingelheim am Rhein, Germany
Problems found, fixed voluntarily at FDA's last inspection, May 15, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Atropine | Makes the active ingredient and tests it |
Alcon Laboratories, Inc. |
0065-0303, 0065-0817 |
| Dabigatran | Makes it, makes the active ingredient, tests it, packages it and labels it |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0108, 0597-0355, 0597-0360 +6 |
| Empagliflozin and Linagliptin | Makes it, makes the active ingredient, packages it and labels it |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0164, 0597-0182 |
| Epinephrine | Makes the active ingredient |
Amneal Pharmaceuticals |
0115-1694, 0115-1695 |
| Hydrochlorothiazide and Telmisartan | Makes it, packages it and labels it |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0042, 0597-0043, 0597-0044 |
| Linagliptin | Makes the active ingredient |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0140 |
| Linagliptin and Metformin | Makes it, makes the active ingredient, packages it and labels it |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0146, 0597-0147, 0597-0148 |
| Olodaterol | Makes it, makes the active ingredient, packages it and labels it |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0192 |
| Olodaterol and Tiotropium | Makes it, makes the active ingredient, packages it and labels it |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0155 |
| Tipranavir | Makes the active ingredient |
Boehringer Ingelheim Pharmaceuticals, Inc. |
0597-0003 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| May 15, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 7, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 4, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 8, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 7, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 12, 2012 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 5, 2010 | No problems found | Drug Quality Assurance | — |
| Jun 5, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.