Aromatika Ltd
⚠️ High Risk
FEI: 3009681660 • Kiev • UKRAINE
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/8/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Aromatika Ltd's FDA import refusal history?
Aromatika Ltd (FEI: 3009681660) has 9 FDA import refusal record(s) in our database, spanning from 12/8/2015 to 12/8/2015.
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. Aromatika Ltd's FEI number is 3009681660.
What types of violations has Aromatika Ltd received?
Aromatika 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 Aromatika Ltd come from?
All FDA import refusal data for Aromatika 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.