Hk Powerful Development Ltd
⚠️ Moderate Risk
FEI: 3010378101 • Guangzhou • CHINA
FEI Number
3010378101
Location
Guangzhou
Country
CHINAAddress
Room 101, 7th Fl. No. 20 Yuan Cun Tianhe, , Guangzhou, , 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 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).
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2013 | 95REAHIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW) | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 95REAHIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW) | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 95REAHIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW) | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 95REAHIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW) | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 95REAHIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW) | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79NRJULTRASOUND, SKIN PERMEATION | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79OUHSKIN RESURFACING RF APPLICATOR | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79FTCLIGHT, ULTRAVIOLET, DERMATOLOGICAL | San Francisco District Office (SAN-DO) | |
| 12/3/2013 | 79OUHSKIN RESURFACING RF APPLICATOR | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Hk Powerful Development Ltd's FDA import refusal history?
Hk Powerful Development Ltd (FEI: 3010378101) has 9 FDA import refusal record(s) in our database, spanning from 12/3/2013 to 12/3/2013.
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. Hk Powerful Development Ltd's FEI number is 3010378101.
What types of violations has Hk Powerful Development Ltd received?
Hk Powerful Development 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 Hk Powerful Development Ltd come from?
All FDA import refusal data for Hk Powerful Development 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.