Best Green Industrial Company
⚠️ High Risk
FEI: 3011257248 • Dakan Cun Xi Li • CHINA
FEI Number
3011257248
Location
Dakan Cun Xi Li
Country
CHINAAddress
2nd Floor No. 12, Industry 2nd, , Dakan Cun Xi Li, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2017 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 7/7/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 6/22/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 5/31/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/27/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/27/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/25/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 5/24/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/12/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/4/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/4/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 4/28/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 4/22/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 4/18/2016 | 89IROVIBRATOR, THERAPEUTIC | New Orleans District Office (NOL-DO) | |
| 4/15/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 4/4/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 3/24/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 3/18/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 3/18/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 3/18/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 3/14/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 2/23/2016 | 78PIAVIBRATOR FOR CLIMAX CONTROL OF PREMATURE EJACULATION | Division of Southeast Imports (DSEI) | |
| 2/23/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 1/29/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 1/27/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 1/27/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 1/15/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 12/11/2015 | 89IROVIBRATOR, THERAPEUTIC | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 11/17/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 10/30/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 10/28/2015 | 78FHWDEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 10/28/2015 | 85KXQVIBRATOR FOR THERAPEUTIC USE, GENITAL | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 9/23/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 9/23/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 9/17/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/16/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 8/4/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 7/21/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/28/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/24/2015 | 89IROVIBRATOR, THERAPEUTIC | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/24/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/21/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/6/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 223FALSE | Division of Southeast Imports (DSEI) |
| 3/16/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/16/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/24/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Best Green Industrial Company's FDA import refusal history?
Best Green Industrial Company (FEI: 3011257248) has 46 FDA import refusal record(s) in our database, spanning from 2/24/2015 to 4/12/2017.
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. Best Green Industrial Company's FEI number is 3011257248.
What types of violations has Best Green Industrial Company received?
Best Green Industrial Company 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 Best Green Industrial Company come from?
All FDA import refusal data for Best Green Industrial Company 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.