Shamrock Gift Co.Ltd.
✅ Low Risk
FEI: 3002780784 • Dublin 22 • IRELAND
FEI Number
3002780784
Location
Dublin 22
Country
IRELANDAddress
Unit 10 Business Centrefonthill, , Dublin 22, , Ireland
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Shamrock Gift Co.Ltd.'s FDA import refusal history?
Shamrock Gift Co.Ltd. (FEI: 3002780784) has 1 FDA import refusal record(s) in our database, spanning from 9/17/2009 to 9/17/2009.
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. Shamrock Gift Co.Ltd.'s FEI number is 3002780784.
What types of violations has Shamrock Gift Co.Ltd. received?
Shamrock Gift Co.Ltd. 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 Shamrock Gift Co.Ltd. come from?
All FDA import refusal data for Shamrock Gift Co.Ltd. 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.