Foshan R. Poon Medical Products Co., Ltd.
⚠️ Moderate Risk
FEI: 1000282279 • Foshan, Guangdong • CHINA
FEI Number
1000282279
Location
Foshan, Guangdong
Country
CHINAAddress
District, Danzao Avenue; Danzaozhen Nanhai, Foshan, 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
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 |
|---|---|---|---|
| 8/17/2007 | 89IPRCRUTCH | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/17/2007 | 89KTCBATH, SITZ, NONPOWERED | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/17/2007 | 89IORWHEELCHAIR, MECHANICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/17/2007 | 80FNLBED, AC-POWERED ADJUSTABLE HOSPITAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/17/2007 | 89IPSCANE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/17/2007 | 89KHYCANE, SAFETY WALK | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Foshan R. Poon Medical Products Co., Ltd.'s FDA import refusal history?
Foshan R. Poon Medical Products Co., Ltd. (FEI: 1000282279) has 6 FDA import refusal record(s) in our database, spanning from 8/17/2007 to 8/17/2007.
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. Foshan R. Poon Medical Products Co., Ltd.'s FEI number is 1000282279.
What types of violations has Foshan R. Poon Medical Products Co., Ltd. received?
Foshan R. Poon Medical Products Co., Ltd. has been cited for 1 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 Foshan R. Poon Medical Products Co., Ltd. come from?
All FDA import refusal data for Foshan R. Poon Medical Products Co., Ltd. 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.