BEIJING HONKON TECHNOLOGIES CO., LTD.
⚠️ Moderate Risk
FEI: 3009488834 • Beijing, Beijing • CHINA
FEI Number
3009488834
Location
Beijing, Beijing
Country
CHINAAddress
Building 72, NO. 16 Huanke Middle Road; Tongzhou, Beijing, 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
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.
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).
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.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 |
|---|---|---|---|
| 4/18/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 12/11/2015 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 7/20/2015 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | Seattle District Office (SEA-DO) | |
| 7/20/2015 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | Seattle District Office (SEA-DO) | |
| 3/30/2015 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | Cincinnati District Office (CIN-DO) | |
| 2/19/2015 | 89HPHDIATHERMY, MICROWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) | |
| 9/23/2013 | 89LBFDEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY | Los Angeles District Office (LOS-DO) | |
| 7/23/2012 | 89ONHPOWERED LASER NON-THEMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJUNCTIVE USE IN PATH THERAPY | Cincinnati District Office (CIN-DO) | |
| 6/4/2012 | 79GFEBRUSH, DERMABRASION | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is BEIJING HONKON TECHNOLOGIES CO., LTD.'s FDA import refusal history?
BEIJING HONKON TECHNOLOGIES CO., LTD. (FEI: 3009488834) has 9 FDA import refusal record(s) in our database, spanning from 6/4/2012 to 4/18/2017.
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 HONKON TECHNOLOGIES CO., LTD.'s FEI number is 3009488834.
What types of violations has BEIJING HONKON TECHNOLOGIES CO., LTD. received?
BEIJING HONKON TECHNOLOGIES CO., LTD. has been cited for 9 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 HONKON TECHNOLOGIES CO., LTD. come from?
All FDA import refusal data for BEIJING HONKON TECHNOLOGIES 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.