Yixing Yafeng Thermal Protection Pr
⚠️ Moderate Risk
FEI: 3010372441 • Wuxishi, Jiangsusheng • CHINA
FEI Number
3010372441
Location
Wuxishi, Jiangsusheng
Country
CHINAAddress
Wupo Bridge, Xinzhuang Town, Yixing, , Wuxishi, Jiangsusheng, 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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/27/2013 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | Cincinnati District Office (CIN-DO) | |
| 11/27/2013 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | Cincinnati District Office (CIN-DO) | |
| 11/25/2013 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | Cincinnati District Office (CIN-DO) | |
| 11/22/2013 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Yixing Yafeng Thermal Protection Pr's FDA import refusal history?
Yixing Yafeng Thermal Protection Pr (FEI: 3010372441) has 4 FDA import refusal record(s) in our database, spanning from 11/22/2013 to 11/27/2013.
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. Yixing Yafeng Thermal Protection Pr's FEI number is 3010372441.
What types of violations has Yixing Yafeng Thermal Protection Pr received?
Yixing Yafeng Thermal Protection Pr has been cited for 3 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 Yixing Yafeng Thermal Protection Pr come from?
All FDA import refusal data for Yixing Yafeng Thermal Protection Pr 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.