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Boehringer Ingelheim Animal Health Puerto Rico LLC

⚠️ Moderate Risk

FEI: 2623436 • Barceloneta, PR • UNITED STATES

FEI

FEI Number

2623436

📍

Location

Barceloneta, PR

🇺🇸
🏢

Address

Rd #2 Kilometer 56.7, , Barceloneta, PR, United States

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
9/9/2020
Latest Refusal
11/24/2014
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
5.2×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
9/9/2020
60ZRA15IVERMECTIN AND COMBINATIONS (ANTIPARASITIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Boehringer Ingelheim Animal Health Puerto Rico LLC's FDA import refusal history?

Boehringer Ingelheim Animal Health Puerto Rico LLC (FEI: 2623436) has 3 FDA import refusal record(s) in our database, spanning from 11/24/2014 to 9/9/2020.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Boehringer Ingelheim Animal Health Puerto Rico LLC's FEI number is 2623436.

What types of violations has Boehringer Ingelheim Animal Health Puerto Rico LLC received?

Boehringer Ingelheim Animal Health Puerto Rico LLC has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Boehringer Ingelheim Animal Health Puerto Rico LLC come from?

All FDA import refusal data for Boehringer Ingelheim Animal Health Puerto Rico LLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.