Nanjiang Foreign Economic & Trade
⚠️ Moderate Risk
FEI: 3002786611 • Nanjiang • 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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 7/16/2018 | 80FMFSYRINGE, PISTON | Division of Northeast Imports (DNEI) | |
| 1/13/2015 | 56CCK70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 1/13/2015 | 56CCK60CEFOTAXIME SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 1/13/2015 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Nanjiang Foreign Economic & Trade's FDA import refusal history?
Nanjiang Foreign Economic & Trade (FEI: 3002786611) has 4 FDA import refusal record(s) in our database, spanning from 1/13/2015 to 7/16/2018.
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. Nanjiang Foreign Economic & Trade's FEI number is 3002786611.
What types of violations has Nanjiang Foreign Economic & Trade received?
Nanjiang Foreign Economic & Trade 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 Nanjiang Foreign Economic & Trade come from?
All FDA import refusal data for Nanjiang Foreign Economic & Trade 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.