Wuxi Medical lnstrument Factory Co., Ltd.
⚠️ Moderate Risk
FEI: 3006851654 • Wuxi, Jiangsu • CHINA
FEI Number
3006851654
Location
Wuxi, Jiangsu
Country
CHINAAddress
D,Zhangjing, Xibei, No. 43 Xixin Road; Xibeizhen Xishan District, Wuxi, Jiangsu, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2012 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/28/2012 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/28/2012 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/28/2012 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/27/2012 | 62FBY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/27/2012 | 62FBY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/27/2012 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Wuxi Medical lnstrument Factory Co., Ltd.'s FDA import refusal history?
Wuxi Medical lnstrument Factory Co., Ltd. (FEI: 3006851654) has 7 FDA import refusal record(s) in our database, spanning from 2/27/2012 to 9/28/2012.
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. Wuxi Medical lnstrument Factory Co., Ltd.'s FEI number is 3006851654.
What types of violations has Wuxi Medical lnstrument Factory Co., Ltd. received?
Wuxi Medical lnstrument Factory 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 Wuxi Medical lnstrument Factory Co., Ltd. come from?
All FDA import refusal data for Wuxi Medical lnstrument Factory 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.