TENGA CO., LTD
⚠️ Moderate Risk
FEI: 3012965321 • Nakano, Tokyo • JAPAN
FEI Number
3012965321
Location
Nakano, Tokyo
Country
JAPANAddress
1 Chome 23-9 Bldg 3f, Hon-Cho, Nakano, Tokyo, Japan
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 473LABELING | Atlanta District Office (ATL-DO) |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Atlanta District Office (ATL-DO) | |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Atlanta District Office (ATL-DO) | |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Atlanta District Office (ATL-DO) | |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Atlanta District Office (ATL-DO) | |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Atlanta District Office (ATL-DO) | |
| 12/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 5/6/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 10/8/2015 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 10/8/2015 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/14/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TENGA CO., LTD's FDA import refusal history?
TENGA CO., LTD (FEI: 3012965321) has 20 FDA import refusal record(s) in our database, spanning from 4/14/2015 to 12/20/2016.
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. TENGA CO., LTD's FEI number is 3012965321.
What types of violations has TENGA CO., LTD received?
TENGA CO., LTD 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 TENGA CO., LTD come from?
All FDA import refusal data for TENGA CO., LTD 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.