Anposi Products Ltd
⚠️ Moderate Risk
FEI: 3005918340 • Shenzhenshenzhen • CHINA
FEI Number
3005918340
Location
Shenzhenshenzhen
Country
CHINAAddress
F/2, NO 28 East of Zhong He Lo Rdyi Tain, Shenzhenshenzhen, , 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2006 | 76LXDDEVICE, OPTICAL CARRIES DETECTION | Seattle District Office (SEA-DO) | |
| 10/19/2006 | 76LXDDEVICE, OPTICAL CARRIES DETECTION | Seattle District Office (SEA-DO) | |
| 10/19/2006 | 76LXDDEVICE, OPTICAL CARRIES DETECTION | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Anposi Products Ltd's FDA import refusal history?
Anposi Products Ltd (FEI: 3005918340) has 3 FDA import refusal record(s) in our database, spanning from 10/19/2006 to 10/19/2006.
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. Anposi Products Ltd's FEI number is 3005918340.
What types of violations has Anposi Products Ltd received?
Anposi Products Ltd 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 Anposi Products Ltd come from?
All FDA import refusal data for Anposi Products 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.