Boehringer Ingelheim RCV GmbH & Co KG FDA Record

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

  • Latest inspection VAI · Jul 4, 2025
  • No warning letters matched by name
Inspections 10 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Boehringer Ingelheim RCV GmbH & Co KG has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boehringer Ingelheim RCV GmbH & Co KG" is on file.

What these totals cover: FDA records filed under the name "Boehringer Ingelheim RCV GmbH & Co KG" and its spelling variant "Boehringer Ingelheim Rcv Gmbh And Co Kg". 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
Jul 4, 2025 · VAI

Newer recall under related name Boehringer Ingelheim Pharmaceuticals: Jun 12, 2026, D-0657-2026.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections10Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Boehringer Ingelheim RCV GmbH & Co KG's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Boehringer Ingelheim RCV GmbH & Co KG: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202410000
202310000
202210000
202110000
202000000
201900000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

10 inspections from Jan 28, 2010 to Jul 4, 2025.

DateSiteProductClassificationFEI
Jul 4, 2025Vienna, AustriaDrugsVoluntary Action Indicated (VAI)3003433722
Nov 12, 2024Vienna, AustriaBiologicsNo Action Indicated (NAI)3003433722
Mar 2, 2023Vienna, AustriaDrugsNo Action Indicated (NAI)3003433722
Sep 16, 2022Vienna, AustriaBiologicsNo Action Indicated (NAI)3003433722
Jan 28, 2021Vienna, AustriaDrugsVoluntary Action Indicated (VAI)3003433722
Nov 11, 2014Vienna, AustriaDrugsVoluntary Action Indicated (VAI)3003433722
Nov 15, 2013Vienna, AustriaDrugsNo Action Indicated (NAI)3003433722
Apr 26, 2013Vienna, AustriaDrugsVoluntary Action Indicated (VAI)3003433722
Mar 23, 2012Vienna, AustriaDrugsVoluntary Action Indicated (VAI)3003433722
Jan 28, 2010Vienna, AustriaDrugsVoluntary Action Indicated (VAI)3003433722
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 3003433722Vienna, Austria10Jul 4, 2025

Boehringer Ingelheim RCV GmbH & Co KG and the FDA: common questions

Has Boehringer Ingelheim RCV GmbH & Co KG received an FDA warning letter?

No FDA warning letter addressed to the name "Boehringer Ingelheim RCV GmbH & Co KG" 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 RCV GmbH & Co KG received an FDA Form 483?

FDA has not published a Form 483 for "Boehringer Ingelheim RCV GmbH & Co KG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Boehringer Ingelheim RCV GmbH & Co KG?

The most recent FDA inspection on file ended Jul 4, 2025 at Vienna, Austria and was classified VAI. FDA has 10 inspections of Boehringer Ingelheim RCV GmbH & Co KG on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.