FULL POWER LOGISTICS LIMITED
✅ Low Risk
FEI: 3012868383 • Shenzhen • CHINA
FEI Number
3012868383
Location
Shenzhen
Country
CHINAAddress
23F West Tower of Wenhu, , Shenzhen, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2016 | 76JEQTOOTHBRUSH, POWERED | Southwest Import District Office (SWI-DO) | |
| 12/8/2016 | 76JEQTOOTHBRUSH, POWERED | Southwest Import District Office (SWI-DO) | |
| 12/8/2016 | 76EFWTOOTHBRUSH, MANUAL | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is FULL POWER LOGISTICS LIMITED's FDA import refusal history?
FULL POWER LOGISTICS LIMITED (FEI: 3012868383) has 3 FDA import refusal record(s) in our database, spanning from 12/8/2016 to 12/8/2016.
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. FULL POWER LOGISTICS LIMITED's FEI number is 3012868383.
What types of violations has FULL POWER LOGISTICS LIMITED received?
FULL POWER LOGISTICS LIMITED has been cited for 6 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 FULL POWER LOGISTICS LIMITED come from?
All FDA import refusal data for FULL POWER LOGISTICS LIMITED 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.