Smash Box Studio
⚠️ Moderate Risk
FEI: 3000141410 • Culver City, CA • UNITED STATES
FEI Number
3000141410
Location
Culver City, CA
Country
UNITED STATESAddress
8549 Higuera St, , Culver City, CA, United States
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
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2009 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | Los Angeles District Office (LOS-DO) |
| 11/4/2009 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | Los Angeles District Office (LOS-DO) |
| 11/4/2009 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Los Angeles District Office (LOS-DO) |
| 11/4/2009 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 4/7/2004 | 53GK03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 473LABELING | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Smash Box Studio's FDA import refusal history?
Smash Box Studio (FEI: 3000141410) has 6 FDA import refusal record(s) in our database, spanning from 4/7/2004 to 11/4/2009.
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. Smash Box Studio's FEI number is 3000141410.
What types of violations has Smash Box Studio received?
Smash Box Studio has been cited for 4 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 Smash Box Studio come from?
All FDA import refusal data for Smash Box Studio 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.