China National Agricultural Machinery Import/Export Corp
⚠️ Moderate Risk
FEI: 1000535995 • Beijing Cn • CHINA
FEI Number
1000535995
Location
Beijing Cn
Country
CHINAAddress
26 South Yuetan St, , Beijing Cn, , 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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2013 | 80KZFDEVICE, MEDICAL EXAMINATION, AC POWERED | Florida District Office (FLA-DO) | |
| 1/31/2013 | 80KZFDEVICE, MEDICAL EXAMINATION, AC POWERED | Florida District Office (FLA-DO) | |
| 1/31/2013 | 80KZFDEVICE, MEDICAL EXAMINATION, AC POWERED | Division of Southeast Imports (DSEI) | |
| 1/31/2013 | 80KZFDEVICE, MEDICAL EXAMINATION, AC POWERED | Division of Southeast Imports (DSEI) | |
| 1/31/2013 | 80KZFDEVICE, MEDICAL EXAMINATION, AC POWERED | Division of Southeast Imports (DSEI) | |
| 11/28/2012 | 80KZFDEVICE, MEDICAL EXAMINATION, AC POWERED | 84RX DEVICE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is China National Agricultural Machinery Import/Export Corp's FDA import refusal history?
China National Agricultural Machinery Import/Export Corp (FEI: 1000535995) has 6 FDA import refusal record(s) in our database, spanning from 11/28/2012 to 1/31/2013.
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. China National Agricultural Machinery Import/Export Corp's FEI number is 1000535995.
What types of violations has China National Agricultural Machinery Import/Export Corp received?
China National Agricultural Machinery Import/Export Corp has been cited for 3 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 China National Agricultural Machinery Import/Export Corp come from?
All FDA import refusal data for China National Agricultural Machinery Import/Export Corp 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.