JIANGSU NEW ERA INDUSTRIAL & TRA
⚠️ Moderate Risk
FEI: 3012811011 • Nanjing • CHINA
FEI Number
3012811011
Location
Nanjing
Country
CHINAAddress
402 East Zhongshan Rd N, , Nanjing, , 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
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2017 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 9/11/2008 | 80LGXTABLE, EXAMINATION, MEDICAL, POWERED | Florida District Office (FLA-DO) | |
| 9/11/2008 | 80FRWSCALE, PATIENT | Florida District Office (FLA-DO) | |
| 9/11/2008 | 80FLESTERILIZER, STEAM | Florida District Office (FLA-DO) | |
| 9/11/2008 | 73BXHGAUGE, GAS PRESSURE, CYLINDER/PIPELINE | Florida District Office (FLA-DO) | |
| 9/11/2008 | 74LDESTETHOSCOPE, MANUAL | Florida District Office (FLA-DO) | |
| 9/11/2008 | 73OBNHUMIDIFIER, RESPIRATORY, MASK (DIRECT PATIENT INTERFACE) | Florida District Office (FLA-DO) | |
| 9/11/2008 | 73OBNHUMIDIFIER, RESPIRATORY, MASK (DIRECT PATIENT INTERFACE) | Florida District Office (FLA-DO) | |
| 9/11/2008 | 80FRWSCALE, PATIENT | Florida District Office (FLA-DO) | |
| 9/11/2008 | 79IOBLAMP, INFRARED, PHYSICAL MEDICINE | Florida District Office (FLA-DO) | |
| 9/11/2008 | 80FLESTERILIZER, STEAM | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is JIANGSU NEW ERA INDUSTRIAL & TRA's FDA import refusal history?
JIANGSU NEW ERA INDUSTRIAL & TRA (FEI: 3012811011) has 11 FDA import refusal record(s) in our database, spanning from 9/11/2008 to 10/19/2017.
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. JIANGSU NEW ERA INDUSTRIAL & TRA's FEI number is 3012811011.
What types of violations has JIANGSU NEW ERA INDUSTRIAL & TRA received?
JIANGSU NEW ERA INDUSTRIAL & TRA 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 JIANGSU NEW ERA INDUSTRIAL & TRA come from?
All FDA import refusal data for JIANGSU NEW ERA INDUSTRIAL & TRA 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.