Boehringer Ingelheim Espana S.A. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

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.

What these totals cover: FDA records filed under the name "Boehringer Ingelheim Espana S.A." and its spelling variant "Boehringer Ingelheim Espana". Records filed under related names are not included; see Related names.

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

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

1 inspection on Jun 30, 2023.

DateSiteProductClassificationFEI
Jun 30, 2023Sant Cugat Del Valles, SpainDrugsVoluntary 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3008772184Sant Cugat Del Valles, Spain1Jun 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.