Lovely Planet
⚠️ Moderate Risk
FEI: 3008146431 • Marseille, Bouches du Rhone • FRANCE
FEI Number
3008146431
Location
Marseille, Bouches du Rhone
Country
FRANCEAddress
54 Rue Gaston De Flotte, , Marseille, Bouches du Rhone, France
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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/23/2015 | 89IROVIBRATOR, THERAPEUTIC | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 6/23/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 6/23/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/24/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/23/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 4/14/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 3/27/2015 | 89IROVIBRATOR, THERAPEUTIC | 223FALSE | New Orleans District Office (NOL-DO) |
| 3/20/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 223FALSE | Division of Southeast Imports (DSEI) |
| 3/4/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 2/24/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 1/22/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 11/7/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 6/13/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lovely Planet's FDA import refusal history?
Lovely Planet (FEI: 3008146431) has 15 FDA import refusal record(s) in our database, spanning from 6/13/2014 to 7/21/2015.
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. Lovely Planet's FEI number is 3008146431.
What types of violations has Lovely Planet received?
Lovely Planet 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 Lovely Planet come from?
All FDA import refusal data for Lovely Planet 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.