Boehringer Ingelheim Animal Health USA Inc FDA Inspection Record
Boehringer Ingelheim Animal Health USA Inc is an FDA-inspected facility (FEI 3003809686) located in Duluth, GA, US. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Dec 19, 2019: No Action Indicated (NAI)
- Inspections on record
- 2 (2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Mar 1, 2024
- Recalls as the recalling firm
- 5, latest Jun 30, 2023
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 19, 2019 | No Action Indicated (NAI) | No citations listed |
| Nov 8, 2013 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 30, 2023 | Class II | V-0149-2023 | Semintra (telmisartan oral solution) 10 mg/mL For oral use in cats only Angiotensin II… Out of specification for pH and precipitation formation. |
| Sep 30, 2020 | Class III | V-0001-2021 | Vetmedin (pimobendan) Chewable Tablets, 1.25 mg Net Contents: 50 Tablets NDC 0010-4480-01… cGMP Deviations |
| Aug 13, 2020 | Class III | V-0468-2020 | Heartgard (ivermectin) For Dogs Up To 25 lbs 6 Tablets Each tablet contains 68 mcg… and 2 more products Out of specification for impurity. |
| Mar 2, 2016 | Class II | V-487-2016 | Ivomec (Ivermectin) Injection for Cattle and Swine 1% Sterile Solution, 50 mL, Distributed… Out-of-specification (OOS) assay value for the 12 month, 25C/60% RH, ongoing stability sample of Ivomec (Ivermectin 1%) Injection. |
| Sep 22, 2010 | Class III | V-060-2011 | IVOMEC (ivermectin) Sheep Drench, SKU #67711 (Single 1 liter) and SKU #67710 (case 4.1… Incorrect date of expiry. Product states 60 months; correct expiry date is 36 months. |
FDA record score
11 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
3 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Warning letter with a close-out letter | Mar 1, 2024 | 15 x 0.6 | 9 |
| Class II recall V-0149-2023, this FEI as the recalling firm | Jun 30, 2023 | 4 x 0.6 | 2.4 |
| Class II recall V-487-2016, this FEI as the recalling firm | Mar 2, 2016 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Boehringer Ingelheim Animal Health USA Inc
- Location
- Duluth, GA (US)
- Source
- inspections