Heliz Trading Services
⚠️ Moderate Risk
FEI: 3006062157 • Tortola • BRITISH VIRGIN ISLANDS
FEI Number
3006062157
Location
Tortola
Country
BRITISH VIRGIN ISLANDSAddress
Trident House, , Tortola, , British Virgin Islands
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2022 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/5/2022 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/5/2022 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Heliz Trading Services's FDA import refusal history?
Heliz Trading Services (FEI: 3006062157) has 3 FDA import refusal record(s) in our database, spanning from 4/5/2022 to 4/5/2022.
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. Heliz Trading Services's FEI number is 3006062157.
What types of violations has Heliz Trading Services received?
Heliz Trading Services 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 Heliz Trading Services come from?
All FDA import refusal data for Heliz Trading Services 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.