SHENZHEN BAOFENG INTERNATIONAL L
⚠️ Moderate Risk
FEI: 3013555392 • SHANGHAI • CHINA
FEI Number
3013555392
Location
SHANGHAI
Country
CHINAAddress
HUA ZHI RD 1295 NONG 88, , 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
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.
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).
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2021 | 86LRXCASE, CONTACT LENS | Division of Southeast Imports (DSEI) | |
| 9/16/2019 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) | |
| 6/25/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 5/16/2018 | 87HXYBRACE, DRILL | Division of Southeast Imports (DSEI) | |
| 4/30/2018 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 3/8/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 2/22/2018 | 73MIANEEDLE, SPINAL, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 2/20/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 1/2/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 1/2/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 1/2/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 10/11/2017 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN BAOFENG INTERNATIONAL L's FDA import refusal history?
SHENZHEN BAOFENG INTERNATIONAL L (FEI: 3013555392) has 13 FDA import refusal record(s) in our database, spanning from 10/11/2017 to 6/7/2021.
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. SHENZHEN BAOFENG INTERNATIONAL L's FEI number is 3013555392.
What types of violations has SHENZHEN BAOFENG INTERNATIONAL L received?
SHENZHEN BAOFENG INTERNATIONAL L 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 SHENZHEN BAOFENG INTERNATIONAL L come from?
All FDA import refusal data for SHENZHEN BAOFENG INTERNATIONAL L 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.