Shanghai World Prospect Ind. Co. Ltd.
⚠️ Moderate Risk
FEI: 3004853654 • Shanghai • CHINA
FEI Number
3004853654
Location
Shanghai
Country
CHINAAddress
8th Fl, No 88 Building1199 North Qinzhou, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2008 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Seattle District Office (SEA-DO) | |
| 5/31/2007 | 66SCS03BETAHISTINE HCL (VASODILATOR) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 11/17/2005 | 62FCJ29NITROFURAZONE (ANTI-INFECTIVE, TOPICAL) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shanghai World Prospect Ind. Co. Ltd.'s FDA import refusal history?
Shanghai World Prospect Ind. Co. Ltd. (FEI: 3004853654) has 3 FDA import refusal record(s) in our database, spanning from 11/17/2005 to 10/16/2008.
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 World Prospect Ind. Co. Ltd.'s FEI number is 3004853654.
What types of violations has Shanghai World Prospect Ind. Co. Ltd. received?
Shanghai World Prospect Ind. 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 World Prospect Ind. Co. Ltd. come from?
All FDA import refusal data for Shanghai World Prospect Ind. 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.