Dongguang Sunway Hardware & Pla
⚠️ Moderate Risk
FEI: 3007546390 • Hamen City • CHINA
FEI Number
3007546390
Location
Hamen City
Country
CHINAAddress
Ziya 2 Road West Lake Developmen, , Hamen City, , 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
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.
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).
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.
NON STD
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 offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2009 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Seattle District Office (SEA-DO) | |
| 7/1/2009 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Dongguang Sunway Hardware & Pla's FDA import refusal history?
Dongguang Sunway Hardware & Pla (FEI: 3007546390) has 2 FDA import refusal record(s) in our database, spanning from 7/1/2009 to 7/1/2009.
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. Dongguang Sunway Hardware & Pla's FEI number is 3007546390.
What types of violations has Dongguang Sunway Hardware & Pla received?
Dongguang Sunway Hardware & Pla has been cited for 4 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 Dongguang Sunway Hardware & Pla come from?
All FDA import refusal data for Dongguang Sunway Hardware & Pla 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.