Royal Sea
⚠️ Moderate Risk
FEI: 3013530800 • Tel Aviv • ISRAEL
FEI Number
3013530800
Location
Tel Aviv
Country
ISRAELAddress
Kehilat Lodge 18, , Tel Aviv, , Israel
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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
Frequently Asked Questions
What is Royal Sea's FDA import refusal history?
Royal Sea (FEI: 3013530800) has 1 FDA import refusal record(s) in our database, spanning from 9/18/2017 to 9/18/2017.
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. Royal Sea's FEI number is 3013530800.
What types of violations has Royal Sea received?
Royal Sea 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 Royal Sea come from?
All FDA import refusal data for Royal Sea 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.