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Haleon US Inc.

⚠️ Moderate Risk

FEI: 1911445 • Lincoln, NE • UNITED STATES

FEI

FEI Number

1911445

📍

Location

Lincoln, NE

🇺🇸
🏢

Address

10401 Us Highway 6, , Lincoln, NE, United States

Moderate Risk

FDA Import Risk Assessment

34.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
7/27/2020
Latest Refusal
9/15/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.0×10%
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

1792×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

751×

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
7/27/2020
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/13/2005
62CCA99ANTI-HYPERTENSIVE N.E.C.
179AGR RX
Cincinnati District Office (CIN-DO)
9/15/2005
56BCA51PENICILLAMINE (PENICILLIN, SYNTHETICALLY PRODUCED)
179AGR RX
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Haleon US Inc.'s FDA import refusal history?

Haleon US Inc. (FEI: 1911445) has 3 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 7/27/2020.

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. Haleon US Inc.'s FEI number is 1911445.

What types of violations has Haleon US Inc. received?

Haleon US Inc. has been cited for 2 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 Haleon US Inc. come from?

All FDA import refusal data for Haleon US Inc. 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.