Shanghai Bright Kun Industrial Limited
⚠️ Moderate Risk
FEI: 3011808599 • Shanghai, Shanghai • CHINA
FEI Number
3011808599
Location
Shanghai, Shanghai
Country
CHINAAddress
D218 No.168 Jiugan Road, , Shanghai, Shanghai, 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
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.
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.
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 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 |
|---|---|---|---|
| 8/4/2022 | 76MAUERASER, DENTAL STAIN | Division of Southeast Imports (DSEI) | |
| 2/27/2017 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) | |
| 5/20/2016 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shanghai Bright Kun Industrial Limited's FDA import refusal history?
Shanghai Bright Kun Industrial Limited (FEI: 3011808599) has 3 FDA import refusal record(s) in our database, spanning from 5/20/2016 to 8/4/2022.
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. Shanghai Bright Kun Industrial Limited's FEI number is 3011808599.
What types of violations has Shanghai Bright Kun Industrial Limited received?
Shanghai Bright Kun Industrial Limited has been cited for 7 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 Shanghai Bright Kun Industrial Limited come from?
All FDA import refusal data for Shanghai Bright Kun Industrial 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.