Boehringer Ingelheim Animal Health Puerto Rico LLC FDA Record

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

  • Latest inspection VAI · Mar 27, 2024
  • 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 Animal Health Puerto Rico LLC has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boehringer Ingelheim Animal Health Puerto Rico LLC" is on file.

What these totals cover: FDA records filed under the name "Boehringer Ingelheim Animal Health Puerto Rico LLC" and its spelling variant "Boehringer Ingelheim Animal Health Puerto Rico". 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
Mar 27, 2024 · 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 Animal Health Puerto Rico LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Boehringer Ingelheim Animal Health Puerto Rico LLC: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202200000
202110000
202000000
201910000
201800000
201710000

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 May 21, 2009 to Mar 27, 2024.

DateSiteProductClassificationFEI
Mar 27, 2024Barceloneta, PRVeterinaryVoluntary Action Indicated (VAI)2623436
Feb 12, 2021Barceloneta, PRVeterinaryNo Action Indicated (NAI)2623436
Mar 29, 2019Barceloneta, PRVeterinaryVoluntary Action Indicated (VAI)2623436
Feb 3, 2017Barceloneta, PRVeterinaryVoluntary Action Indicated (VAI)2623436
Jul 17, 2015Barceloneta, PRVeterinaryVoluntary Action Indicated (VAI)2623436
Jan 28, 2014Barceloneta, PRDrugsNo Action Indicated (NAI)2623436
Jun 20, 2012Barceloneta, PRVeterinaryVoluntary Action Indicated (VAI)2623436
Mar 22, 2012Barceloneta, PRDrugsNo Action Indicated (NAI)2623436
Mar 31, 2011Barceloneta, PRVeterinaryVoluntary Action Indicated (VAI)2623436
May 21, 2009Barceloneta, PRVeterinaryVoluntary Action Indicated (VAI)2623436
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 2623436Barceloneta, PR10Mar 27, 2024

Boehringer Ingelheim Animal Health Puerto Rico LLC and the FDA: common questions

Has Boehringer Ingelheim Animal Health Puerto Rico LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Boehringer Ingelheim Animal Health Puerto Rico LLC" 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 Animal Health Puerto Rico LLC received an FDA Form 483?

FDA has not published a Form 483 for "Boehringer Ingelheim Animal Health Puerto Rico LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Boehringer Ingelheim Animal Health Puerto Rico LLC?

The most recent FDA inspection on file ended Mar 27, 2024 at Barceloneta, PR and was classified VAI. FDA has 10 inspections of Boehringer Ingelheim Animal Health Puerto Rico LLC on file.

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