RED FUN LTD
⚠️ Moderate Risk
FEI: 3014880383 • Vienna, Vienna • AUSTRIA
FEI Number
3014880383
Location
Vienna, Vienna
Country
AUSTRIAAddress
Dampfschiffstrase 14, , Vienna, Vienna, Austria
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
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).
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 |
|---|---|---|---|
| 6/17/2020 | 66SDY01AMYL NITRITE (VASODILATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 66SDY01AMYL NITRITE (VASODILATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/17/2020 | 66SDY01AMYL NITRITE (VASODILATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/22/2020 | 66SBY99VASODILATOR N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/3/2019 | 66SBY99VASODILATOR N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/27/2019 | 66SBY99VASODILATOR N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is RED FUN LTD's FDA import refusal history?
RED FUN LTD (FEI: 3014880383) has 6 FDA import refusal record(s) in our database, spanning from 6/27/2019 to 6/17/2020.
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. RED FUN LTD's FEI number is 3014880383.
What types of violations has RED FUN LTD received?
RED FUN LTD 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 RED FUN LTD come from?
All FDA import refusal data for RED FUN 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.