Shinning pharmaceutical & chemical Co Ltd
✅ Low Risk
FEI: 3011318530 • Taizhou, Zhejiang • CHINA
FEI Number
3011318530
Location
Taizhou, Zhejiang
Country
CHINAAddress
NO. 17 Tashan Yanlu, Xianjuxian, Taizhou, Zhejiang, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2014 | 61HAS45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shinning pharmaceutical & chemical Co Ltd's FDA import refusal history?
Shinning pharmaceutical & chemical Co Ltd (FEI: 3011318530) has 1 FDA import refusal record(s) in our database, spanning from 11/25/2014 to 11/25/2014.
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. Shinning pharmaceutical & chemical Co Ltd's FEI number is 3011318530.
What types of violations has Shinning pharmaceutical & chemical Co Ltd received?
Shinning pharmaceutical & chemical Co Ltd has been cited for 1 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 Shinning pharmaceutical & chemical Co Ltd come from?
All FDA import refusal data for Shinning pharmaceutical & chemical 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.