Tonglu Hongyu Sport Products Limited
⚠️ Moderate Risk
FEI: 3013680792 • Hangzhou, Zhejiang • CHINA
FEI Number
3013680792
Location
Hangzhou, Zhejiang
Country
CHINAAddress
100 Jiuxian Street, Tongluxian, Hangzhou, Zhejiang, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/29/2019 | 89ITQJOINT, KNEE, EXTERNAL BRACE | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 89ISRBAND OR BELT, PELVIC SUPPORT | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 89ITQJOINT, KNEE, EXTERNAL BRACE | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 89ITQJOINT, KNEE, EXTERNAL BRACE | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 89IOYSUPPORT, ARM | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 89ISRBAND OR BELT, PELVIC SUPPORT | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 89IQEORTHOSIS, LUMBAR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tonglu Hongyu Sport Products Limited's FDA import refusal history?
Tonglu Hongyu Sport Products Limited (FEI: 3013680792) has 8 FDA import refusal record(s) in our database, spanning from 1/29/2019 to 1/29/2019.
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. Tonglu Hongyu Sport Products Limited's FEI number is 3013680792.
What types of violations has Tonglu Hongyu Sport Products Limited received?
Tonglu Hongyu Sport Products Limited has been cited for 2 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 Tonglu Hongyu Sport Products Limited come from?
All FDA import refusal data for Tonglu Hongyu Sport Products Limited 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.