Boehringer Ingelheim Espana S.A. FDA Record
Boehringer Ingelheim Espana S.A. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boehringer Ingelheim Espana S.A." is on file.
- Latest recall
- D-0657-2026 · Jun 12, 2026 · filed under Boehringer Ingelheim Pharmaceuticals
- Latest inspection
- Jun 30, 2023 · VAI
Newer recall under related name Boehringer Ingelheim Pharmaceuticals: Jun 12, 2026, D-0657-2026.
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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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 30, 2023 | Sant Cugat Del Valles, Spain | Drugs | Voluntary Action Indicated (VAI) | 3008772184 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008772184 | Sant Cugat Del Valles, Spain | 1 | Jun 30, 2023 |
Boehringer Ingelheim Espana S.A. and the FDA: common questions
Has Boehringer Ingelheim Espana S.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Boehringer Ingelheim Espana S.A." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Boehringer Ingelheim Espana S.A. received an FDA Form 483?
FDA has not published a Form 483 for "Boehringer Ingelheim Espana S.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Boehringer Ingelheim Espana S.A.?
The most recent FDA inspection on file ended Jun 30, 2023 at Sant Cugat Del Valles, Spain and was classified VAI. FDA has 1 inspection of Boehringer Ingelheim Espana S.A. on file.
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