Boehringer Ingelheim Animal Health USA Inc. FDA Record
- Latest inspection NAI · Dec 19, 2019
- Last warning letter 2024
Boehringer Ingelheim Animal Health USA Inc. has 0 FDA recalls, 16 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Boehringer Ingelheim Animal Health USA Inc., the most recent on Mar 1, 2024.
- Latest recall
- D-0657-2026 · Jun 12, 2026 · filed under Boehringer Ingelheim Pharmaceuticals
- Latest inspection
- Dec 19, 2019 · NAI
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 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 16 | 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 Animal Health USA Inc.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 1 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 3 | 0 | 0 | 0 | 0 |
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Boehringer Ingelheim Animal Health USA Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Mar 1, 2024 · Letter on fda.gov | False & Misleading Claims/Misbranded | Center for Veterinary Medicine | Oct 2, 2024 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 19, 2019 | Johns Creek, GA | Veterinary | No Action Indicated (NAI) | 3003809686 |
| Oct 26, 2017 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 3004653902 |
| Oct 26, 2017 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 1910185 |
| Oct 26, 2017 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 3010865313 |
| Aug 14, 2015 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 1910185 |
| Jun 12, 2014 | Saint Joseph, MO | Veterinary | Voluntary Action Indicated (VAI) | 1910185 |
| Jun 12, 2014 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 3004653902 |
| Jun 12, 2014 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 3010865313 |
| Nov 8, 2013 | Johns Creek, GA | Veterinary | No Action Indicated (NAI) | 3003809686 |
| Feb 6, 2013 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 3004653902 |
| Feb 6, 2013 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 3004653902 |
| Jan 10, 2012 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 1910185 |
| Apr 2, 2010 | Saint Joseph, MO | Veterinary | Voluntary Action Indicated (VAI) | 1910185 |
| Mar 23, 2010 | Saint Joseph, MO | Veterinary | Voluntary Action Indicated (VAI) | 3004653902 |
| Oct 30, 2008 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 3004653902 |
| Oct 30, 2008 | Saint Joseph, MO | Veterinary | No Action Indicated (NAI) | 1910185 |
- 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 Animal Health USA Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003809686 | Johns Creek, GA | 2 | Dec 19, 2019 |
| FEI 1910185 | Saint Joseph, MO | 6 | Oct 26, 2017 |
| FEI 3004653902 | Saint Joseph, MO | 6 | Oct 26, 2017 |
| FEI 3010865313 | Saint Joseph, MO | 2 | Oct 26, 2017 |
Boehringer Ingelheim Animal Health USA Inc. and the FDA: common questions
Has Boehringer Ingelheim Animal Health USA Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Boehringer Ingelheim Animal Health USA Inc.. The most recent is dated Mar 1, 2024, with the subject "False & Misleading Claims/Misbranded".
Has Boehringer Ingelheim Animal Health USA Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Boehringer Ingelheim Animal Health USA Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Boehringer Ingelheim Animal Health USA Inc.?
The most recent FDA inspection on file ended Dec 19, 2019 at Johns Creek, GA and was classified NAI. FDA has 16 inspections of Boehringer Ingelheim Animal Health USA Inc. on file.
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