Haleon US Holdings LLC
⚠️ Moderate Risk
FEI: 1314819 • East Durham, NY • UNITED STATES
FEI Number
1314819
Location
East Durham, NY
Country
UNITED STATESAddress
3169 Route 145, , East Durham, NY, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2024 | 65RBY18SODIUM BICARBONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 6/12/2023 | 65RBY18SODIUM BICARBONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 6/12/2023 | 65RBA18SODIUM BICARBONATE (REPLENISHER) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Haleon US Holdings LLC's FDA import refusal history?
Haleon US Holdings LLC (FEI: 1314819) has 3 FDA import refusal record(s) in our database, spanning from 6/12/2023 to 5/6/2024.
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 Holdings LLC's FEI number is 1314819.
What types of violations has Haleon US Holdings LLC received?
Haleon US Holdings LLC has been cited for 4 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 Holdings LLC come from?
All FDA import refusal data for Haleon US Holdings 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.