Haleon Ireland Dungarvan Limited
⚠️ Moderate Risk
FEI: 3003721894 • Dungarvan, Co. Waterford • IRELAND
FEI Number
3003721894
Location
Dungarvan, Co. Waterford
Country
IRELANDAddress
Knockbrack, , Dungarvan, Co. Waterford, Ireland
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).
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2022 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/11/2021 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 2/26/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 4/3/2019 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/9/2017 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/24/2016 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/4/2010 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/7/2005 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 1/7/2005 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 1/7/2005 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 1/7/2005 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 7/25/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/25/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Haleon Ireland Dungarvan Limited's FDA import refusal history?
Haleon Ireland Dungarvan Limited (FEI: 3003721894) has 14 FDA import refusal record(s) in our database, spanning from 7/25/2003 to 9/2/2022.
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 Ireland Dungarvan Limited's FEI number is 3003721894.
What types of violations has Haleon Ireland Dungarvan Limited received?
Haleon Ireland Dungarvan Limited 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 Ireland Dungarvan Limited come from?
All FDA import refusal data for Haleon Ireland Dungarvan Limited 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.