BEIJING NUBWAY S&T CO., LTD.
⚠️ Moderate Risk
FEI: 3016982670 • Beijing • CHINA
FEI Number
3016982670
Location
Beijing
Country
CHINAAddress
Room 307, 3rd Floor, No.5 Building, Mauhwa Industry Park, No.1 Caida 3rd Street Nancai Town Shunyi District, , Beijing, , China
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
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.
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.
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).
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2019 | 74DWQSTRIPPER, VEIN, EXTERNAL | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 74DWQSTRIPPER, VEIN, EXTERNAL | Division of Southeast Imports (DSEI) | |
| 9/22/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) | |
| 9/22/2017 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | Division of West Coast Imports (DWCI) | |
| 7/20/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is BEIJING NUBWAY S&T CO., LTD.'s FDA import refusal history?
BEIJING NUBWAY S&T CO., LTD. (FEI: 3016982670) has 5 FDA import refusal record(s) in our database, spanning from 7/20/2015 to 3/8/2019.
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. BEIJING NUBWAY S&T CO., LTD.'s FEI number is 3016982670.
What types of violations has BEIJING NUBWAY S&T CO., LTD. received?
BEIJING NUBWAY S&T CO., LTD. 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 BEIJING NUBWAY S&T CO., LTD. come from?
All FDA import refusal data for BEIJING NUBWAY S&T 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.