Fleshlight International
⚠️ Moderate Risk
FEI: 3010038539 • Sevilla, Sevilla • SPAIN
FEI Number
3010038539
Location
Sevilla, Sevilla
Country
SPAINAddress
Calle Breton De Los Herreros 23, , Sevilla, Sevilla, Spain
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
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/31/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 6/23/2015 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 6/23/2015 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 3/16/2015 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/10/2015 | 80KMJLUBRICANT, PATIENT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Fleshlight International's FDA import refusal history?
Fleshlight International (FEI: 3010038539) has 5 FDA import refusal record(s) in our database, spanning from 3/10/2015 to 5/31/2016.
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. Fleshlight International's FEI number is 3010038539.
What types of violations has Fleshlight International received?
Fleshlight International 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 Fleshlight International come from?
All FDA import refusal data for Fleshlight International 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.