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Boehringer Ingelheim Animal Health Puerto Rico LLC FDA Inspection Record

FEI 2623436 · Inspections, Form 483s, warning letters and import refusals

Boehringer Ingelheim Animal Health Puerto Rico LLC is an FDA-registered facility (FEI 2623436) located in Barceloneta, PR, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL. RegDataLab tracks 10 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 27, 2024: Voluntary Action Indicated (VAI)
Inspections on record
10 (7 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
4

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 27, 2024Voluntary Action Indicated (VAI)No citations listed
Feb 12, 2021No Action Indicated (NAI)No citations listed
Mar 29, 2019Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Feb 3, 2017Voluntary Action Indicated (VAI)No citations listed
Jul 17, 2015Voluntary Action Indicated (VAI)Written procedures not established/followed (21 CFR 211.67(b))
Signature and checking of records -- 2 persons (21 CFR 211.186(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Complaint Handling Procedure (21 CFR 211.198(a))
and 2 more
Jan 28, 2014No Action Indicated (NAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Written procedures not established/followed (21 CFR 211.67(b))
Procedures for non-sterile drug products (21 CFR 211.113(a))
Prepared for each batch, include complete information (21 CFR 211.188)
and 1 more
Jun 20, 2012Voluntary Action Indicated (VAI)No citations listed
Mar 22, 2012No Action Indicated (NAI)No citations listed
Mar 31, 2011Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Reserve samples identified, representative, stored (21 CFR 211.170(b))
Annual visual exams of drug products (21 CFR 211.170(b))
May 21, 2009Voluntary Action Indicated (VAI)No citations listed

FDA record score

7 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.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

7 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 27, 20246 x 0.63.6
Inspection classified VAIMar 29, 20196 x 0.251.5
Inspection classified VAIFeb 3, 20176 x 0.251.5
Inspection classified VAIJul 17, 201510 years or older, so it adds no points0
Inspection classified VAIJun 20, 201210 years or older, so it adds no points0
Inspection classified VAIMar 31, 201110 years or older, so it adds no points0
Inspection classified VAIMay 21, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Boehringer Ingelheim Animal Health Puerto Rico LLC
Location
Barceloneta, PR (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL
Source
decrs

Import refusals

FDA data resources

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