Aroma Cosmetics
⚠️ Moderate Risk
FEI: 3008819684 • Sofia • BULGARIA
FEI Number
3008819684
Location
Sofia
Country
BULGARIAAddress
12 Kiril Blagoev Str, , Sofia, , Bulgaria
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
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2016 | 64X06SALICYLIC ACID (KERATOLYTIC) | Division of Northeast Imports (DNEI) | |
| 1/4/2016 | 65L99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/15/2012 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 10/15/2012 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 10/15/2012 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Aroma Cosmetics's FDA import refusal history?
Aroma Cosmetics (FEI: 3008819684) has 5 FDA import refusal record(s) in our database, spanning from 10/15/2012 to 1/4/2016.
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. Aroma Cosmetics's FEI number is 3008819684.
What types of violations has Aroma Cosmetics received?
Aroma Cosmetics has been cited for 4 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 Aroma Cosmetics come from?
All FDA import refusal data for Aroma Cosmetics 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.