Swords Laboratories Unlimited Company
⚠️ High Risk
FEI: 3004531790 • Dublin 15, Co. Dublin • IRELAND
FEI Number
3004531790
Location
Dublin 15, Co. Dublin
Country
IRELANDAddress
Cruiserath Road, , Mulhuddart, Dublin 15, Co. Dublin, 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
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
Frequently Asked Questions
What is Swords Laboratories Unlimited Company's FDA import refusal history?
Swords Laboratories Unlimited Company (FEI: 3004531790) has 2 FDA import refusal record(s) in our database, spanning from 9/3/2025 to 9/3/2025.
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. Swords Laboratories Unlimited Company's FEI number is 3004531790.
What types of violations has Swords Laboratories Unlimited Company received?
Swords Laboratories Unlimited Company has been cited for 1 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 Swords Laboratories Unlimited Company come from?
All FDA import refusal data for Swords Laboratories Unlimited Company 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.