Shanghai J W Co Ltd
⚠️ Moderate Risk
FEI: 3007275348 • Shanghai • CHINA
FEI Number
3007275348
Location
Shanghai
Country
CHINAAddress
No 168 Guijin Village, , 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
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2017 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 63XCR83MANNITOL (DIAGNOSTIC AID) (DRUGS) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shanghai J W Co Ltd's FDA import refusal history?
Shanghai J W Co Ltd (FEI: 3007275348) has 8 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 3/29/2017.
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. Shanghai J W Co Ltd's FEI number is 3007275348.
What types of violations has Shanghai J W Co Ltd received?
Shanghai J W Co Ltd 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 J W Co Ltd come from?
All FDA import refusal data for Shanghai J W Co 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.