CELTIC SEA MINERALS
⚠️ High Risk
FEI: 3004321892 • Cork, Co. CORK • IRELAND
FEI Number
3004321892
Location
Cork, Co. CORK
Country
IRELANDAddress
Currabinny, Main Street, Cork, Co. CORK, Ireland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 6/5/2019 | 54BMT01CALCIUM (MINERAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/5/2019 | 54BMT01CALCIUM (MINERAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/5/2019 | 54BMT01CALCIUM (MINERAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/8/2019 | 54BMT01CALCIUM (MINERAL) | 72NEW VET DR | Division of West Coast Imports (DWCI) |
| 1/17/2019 | 70MY02HORSE MIXED FEED RATION | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 1/17/2019 | 70MY02HORSE MIXED FEED RATION | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 1/17/2019 | 70MY02HORSE MIXED FEED RATION | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is CELTIC SEA MINERALS's FDA import refusal history?
CELTIC SEA MINERALS (FEI: 3004321892) has 7 FDA import refusal record(s) in our database, spanning from 1/17/2019 to 6/5/2019.
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. CELTIC SEA MINERALS's FEI number is 3004321892.
What types of violations has CELTIC SEA MINERALS received?
CELTIC SEA MINERALS 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 CELTIC SEA MINERALS come from?
All FDA import refusal data for CELTIC SEA MINERALS 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.