Guangzhou Renwoxing Hat Industry Li
⚠️ Moderate Risk
FEI: 3010003275 • Guangzhou, Guangdong • CHINA
FEI Number
3010003275
Location
Guangzhou, Guangdong
Country
CHINAAddress
# 5 Yinlan Road, , Guangzhou, Guangdong, 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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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 |
|---|---|---|---|
| 5/28/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) | |
| 5/28/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Guangzhou Renwoxing Hat Industry Li's FDA import refusal history?
Guangzhou Renwoxing Hat Industry Li (FEI: 3010003275) has 2 FDA import refusal record(s) in our database, spanning from 5/28/2013 to 5/28/2013.
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. Guangzhou Renwoxing Hat Industry Li's FEI number is 3010003275.
What types of violations has Guangzhou Renwoxing Hat Industry Li received?
Guangzhou Renwoxing Hat Industry Li 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 Guangzhou Renwoxing Hat Industry Li come from?
All FDA import refusal data for Guangzhou Renwoxing Hat Industry Li 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.