Anji-Yuandong Medical Products Co Ltd
⚠️ Moderate Risk
FEI: 3010448253 • Houzhou City, Zhejiang • CHINA
FEI Number
3010448253
Location
Houzhou City, Zhejiang
Country
CHINAAddress
Baofu Industrial Zone, Anji County, Houzhou City, 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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/26/2017 | 80FQMBANDAGE, ELASTIC | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 10/26/2017 | 80FQMBANDAGE, ELASTIC | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 8/25/2017 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) | |
| 2/27/2017 | 80FQMBANDAGE, ELASTIC | 78STERILITY | Division of Northeast Imports (DNEI) |
| 5/18/2016 | 80FQMBANDAGE, ELASTIC | 304STERILITY | Cincinnati District Office (CIN-DO) |
| 5/18/2016 | 80FQMBANDAGE, ELASTIC | 304STERILITY | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Anji-Yuandong Medical Products Co Ltd's FDA import refusal history?
Anji-Yuandong Medical Products Co Ltd (FEI: 3010448253) has 6 FDA import refusal record(s) in our database, spanning from 5/18/2016 to 10/26/2017.
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. Anji-Yuandong Medical Products Co Ltd's FEI number is 3010448253.
What types of violations has Anji-Yuandong Medical Products Co Ltd received?
Anji-Yuandong Medical Products Co Ltd has been cited for 4 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 Anji-Yuandong Medical Products Co Ltd come from?
All FDA import refusal data for Anji-Yuandong 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.