Guangzhou Beco Electronic
⚠️ Moderate Risk
FEI: 3007408155 • Guangzhou, Guangdong • CHINA
FEI Number
3007408155
Location
Guangzhou, Guangdong
Country
CHINAAddress
113 Huadi Avenue South, Li Wan District, Guangzhou, Guangdong, 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).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2018 | 79MUUSYSTEM, SUCTION, LIPOPLASTY | Division of Southeast Imports (DSEI) | |
| 2/28/2017 | 89IMDPACK, HOT OR COLD, DISPOSABLE | Division of Southeast Imports (DSEI) | |
| 5/27/2015 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 5/22/2013 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | Los Angeles District Office (LOS-DO) | |
| 4/29/2013 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | Seattle District Office (SEA-DO) | |
| 3/15/2013 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | Seattle District Office (SEA-DO) | |
| 3/14/2013 | 79ORKLASER ASSISTED LIPOLYSIS | Seattle District Office (SEA-DO) | |
| 6/28/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 6/4/2012 | 79OUHSKIN RESURFACING RF APPLICATOR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Guangzhou Beco Electronic's FDA import refusal history?
Guangzhou Beco Electronic (FEI: 3007408155) has 9 FDA import refusal record(s) in our database, spanning from 6/4/2012 to 3/2/2018.
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. Guangzhou Beco Electronic's FEI number is 3007408155.
What types of violations has Guangzhou Beco Electronic received?
Guangzhou Beco Electronic has been cited for 11 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 Guangzhou Beco Electronic come from?
All FDA import refusal data for Guangzhou Beco Electronic 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.