Boehringer Ingelheim Pharma GmbH & Co. Kg FDA Record
- Latest inspection VAI · May 15, 2025
- Last warning letter 2013
Boehringer Ingelheim Pharma GmbH & Co. Kg has 0 FDA recalls, 19 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Boehringer Ingelheim Pharma GmbH & Co. Kg, the most recent on May 6, 2013.
- Latest recall
- D-0657-2026 · Jun 12, 2026 · filed under Boehringer Ingelheim Pharmaceuticals
- Latest inspection
- May 15, 2025 · VAI
Newer recall under related name Boehringer Ingelheim Pharmaceuticals: Jun 12, 2026, D-0657-2026.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 19 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Boehringer Ingelheim Pharma GmbH & Co. Kg: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Reviewing Boehringer Ingelheim Pharma GmbH & Co. Kg as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Boehringer Ingelheim Pharma GmbH & Co. Kg yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Boehringer Ingelheim Pharma GmbH & Co. Kg FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| May 6, 2013 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 15, 2025 | Ingelheim Am Rhein, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806556 |
| Jul 22, 2022 | Biberach An Der Riss, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806518 |
| Oct 7, 2021 | Ingelheim Am Rhein, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806556 |
| Sep 19, 2019 | Biberach An Der Riss, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806518 |
| Aug 15, 2019 | Biberach An Der Riss, Germany | Drugs | No Action Indicated (NAI) | 3002806518 |
| Apr 5, 2019 | Biberach An Der Riss, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806518 |
| May 4, 2018 | Ingelheim Am Rhein, Germany | Veterinary | Voluntary Action Indicated (VAI) | 3002806556 |
| Mar 8, 2016 | Ingelheim Am Rhein, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806556 |
| Jan 23, 2015 | Ingelheim Am Rhein, Germany | Devices | No Action Indicated (NAI) | 3002806556 |
| May 30, 2014 | Biberach An Der Riss, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806518 |
| Mar 7, 2014 | Ingelheim Am Rhein, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806556 |
| Mar 19, 2013 | Biberach An Der Riss, Germany | Drugs | No Action Indicated (NAI) | 3002806518 |
| Nov 12, 2012 | Ingelheim Am Rhein, Germany | Drugs | Official Action Indicated (OAI) | 3002806556 |
| Mar 13, 2012 | Biberach An Der Riss, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806518 |
| May 26, 2010 | Biberach An Der Riss, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806518 |
| Feb 5, 2010 | Ingelheim Am Rhein, Germany | Drugs | No Action Indicated (NAI) | 3002806556 |
| Jan 28, 2010 | Biberach An Der Riss, Germany | Drugs | No Action Indicated (NAI) | 3002806518 |
| Jun 5, 2009 | Ingelheim Am Rhein, Germany | Drugs | No Action Indicated (NAI) | 3002806556 |
| May 19, 2009 | Biberach An Der Riss, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002806518 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Boehringer Ingelheim Pharma GmbH & Co. Kg: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002806556 | Ingelheim Am Rhein, Germany | 9 | May 15, 2025 |
| FEI 3002806518 | Biberach An Der Riss, Germany | 10 | Jul 22, 2022 |
Boehringer Ingelheim Pharma GmbH & Co. Kg and the FDA: common questions
Has Boehringer Ingelheim Pharma GmbH & Co. Kg received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Boehringer Ingelheim Pharma GmbH & Co. Kg. The most recent is dated May 6, 2013.
Has Boehringer Ingelheim Pharma GmbH & Co. Kg received an FDA Form 483?
FDA has not published a Form 483 for "Boehringer Ingelheim Pharma GmbH & Co. Kg" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Boehringer Ingelheim Pharma GmbH & Co. Kg?
The most recent FDA inspection on file ended May 15, 2025 at Ingelheim Am Rhein, Germany and was classified VAI. FDA has 19 inspections of Boehringer Ingelheim Pharma GmbH & Co. Kg on file, 1 of them classified OAI (official action indicated).
Need more than this page shows? Ask about Boehringer Ingelheim Pharma GmbH & Co. Kg in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.