Vinco Corporation
⚠️ Moderate Risk
FEI: 3003475851 • Milan • ITALY
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2014 | 64LBJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/6/2009 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2009 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2009 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/5/2008 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Los Angeles District Office (LOS-DO) | |
| 8/5/2008 | 64LAJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Los Angeles District Office (LOS-DO) | |
| 8/5/2008 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/7/2007 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 8/7/2007 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 8/7/2007 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 8/7/2007 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 8/7/2007 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 8/7/2007 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 5/5/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/1/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/22/2006 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 4/14/2004 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 12/30/2003 | 64LDO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Vinco Corporation's FDA import refusal history?
Vinco Corporation (FEI: 3003475851) has 19 FDA import refusal record(s) in our database, spanning from 12/30/2003 to 2/27/2014.
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. Vinco Corporation's FEI number is 3003475851.
What types of violations has Vinco Corporation received?
Vinco Corporation has been cited for 5 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 Vinco Corporation come from?
All FDA import refusal data for Vinco Corporation 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.