Superstar Bv
⚠️ Moderate Risk
FEI: 3008922180 • Oosterhout, Noord-brabant • NETHERLANDS
FEI Number
3008922180
Location
Oosterhout, Noord-brabant
Country
NETHERLANDSAddress
Florijnstraat 12, , Oosterhout, Noord-brabant, Netherlands
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2015 | 53GD11CHILDREN NOVELTY BODY PAINTS | 197COSM COLOR | Cincinnati District Office (CIN-DO) |
| 11/12/2014 | 53GD04LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Cincinnati District Office (CIN-DO) |
| 8/27/2014 | 53GD04LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES) | Cincinnati District Office (CIN-DO) | |
| 7/15/2014 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | Cincinnati District Office (CIN-DO) |
| 7/15/2014 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Cincinnati District Office (CIN-DO) |
| 6/25/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 8/2/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Superstar Bv's FDA import refusal history?
Superstar Bv (FEI: 3008922180) has 7 FDA import refusal record(s) in our database, spanning from 8/2/2012 to 7/16/2015.
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. Superstar Bv's FEI number is 3008922180.
What types of violations has Superstar Bv received?
Superstar Bv has been cited for 7 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 Superstar Bv come from?
All FDA import refusal data for Superstar Bv 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.