BELLROS TRADING LTD N0372787B
⚠️ High Risk
FEI: 3040390276 • Argentona • SPAIN
FEI Number
3040390276
Location
Argentona
Country
SPAINAddress
Recogida: Veinat De Sant Jaume De, Traia 19, Argentona, , Spain
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
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.
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northeast Imports (DNEI) | |
| 12/3/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/3/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/3/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/14/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 11/14/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is BELLROS TRADING LTD N0372787B's FDA import refusal history?
BELLROS TRADING LTD N0372787B (FEI: 3040390276) has 6 FDA import refusal record(s) in our database, spanning from 11/14/2025 to 12/3/2025.
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. BELLROS TRADING LTD N0372787B's FEI number is 3040390276.
What types of violations has BELLROS TRADING LTD N0372787B received?
BELLROS TRADING LTD N0372787B has been cited for 3 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 BELLROS TRADING LTD N0372787B come from?
All FDA import refusal data for BELLROS TRADING LTD N0372787B 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.