DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC
⚠️ Moderate Risk
FEI: 3007689756 • Dongguan • CHINA
FEI Number
3007689756
Location
Dongguan
Country
CHINAAddress
Gang Zi Village, Da Bu Industrial Zone Changping Town, Dongguan, , 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).
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 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).
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2015 | 34FYY02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 3421MELAMINE | Cincinnati District Office (CIN-DO) |
| 12/8/2015 | 76LQXDEVICE, FINGER-SUCKING | Chicago District Office (CHI-DO) | |
| 12/8/2015 | 76LQXDEVICE, FINGER-SUCKING | Chicago District Office (CHI-DO) | |
| 12/8/2015 | 76LQXDEVICE, FINGER-SUCKING | Chicago District Office (CHI-DO) | |
| 7/26/2013 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | Los Angeles District Office (LOS-DO) | |
| 7/26/2013 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC's FDA import refusal history?
DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC (FEI: 3007689756) has 6 FDA import refusal record(s) in our database, spanning from 7/26/2013 to 12/29/2015.
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. DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC's FEI number is 3007689756.
What types of violations has DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC received?
DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC has been cited for 5 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 DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC come from?
All FDA import refusal data for DONGGUAN CHANG PING GANG ZI YAO HENG PLASTIC 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.