Shanghai Fairlong International Trading
⚠️ Moderate Risk
FEI: 3003707637 • Shanghai • 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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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 |
|---|---|---|---|
| 9/26/2003 | 94N14ANALYTICAL X-RAY SYSTEM OR COMPONENT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 7/15/2003 | 80LGXTABLE, EXAMINATION, MEDICAL, POWERED | Florida District Office (FLA-DO) | |
| 10/18/2002 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Shanghai Fairlong International Trading's FDA import refusal history?
Shanghai Fairlong International Trading (FEI: 3003707637) has 3 FDA import refusal record(s) in our database, spanning from 10/18/2002 to 9/26/2003.
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. Shanghai Fairlong International Trading's FEI number is 3003707637.
What types of violations has Shanghai Fairlong International Trading received?
Shanghai Fairlong International Trading 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 Shanghai Fairlong International Trading come from?
All FDA import refusal data for Shanghai Fairlong International Trading 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.