Chang Jiang Leather Co Ltd.
⚠️ Moderate Risk
FEI: 3006986873 • Zhejiang • 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/30/2008 | 65JCS31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Chang Jiang Leather Co Ltd.'s FDA import refusal history?
Chang Jiang Leather Co Ltd. (FEI: 3006986873) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2008 to 9/30/2008.
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. Chang Jiang Leather Co Ltd.'s FEI number is 3006986873.
What types of violations has Chang Jiang Leather Co Ltd. received?
Chang Jiang Leather 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 Chang Jiang Leather Co Ltd. come from?
All FDA import refusal data for Chang Jiang Leather 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.