Suzhou Jianle Fine Chemical Products Co., Ltd
⚠️ Moderate Risk
FEI: 3004578916 • Suzhou • CHINA
FEI Number
3004578916
Location
Suzhou
Country
CHINAAddress
No. 9 South Dong Wu Road, Wuzhong, Jiangsu, Suzhou, , 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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
Frequently Asked Questions
What is Suzhou Jianle Fine Chemical Products Co., Ltd's FDA import refusal history?
Suzhou Jianle Fine Chemical Products Co., Ltd (FEI: 3004578916) has 2 FDA import refusal record(s) in our database, spanning from 10/16/2007 to 1/2/2008.
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. Suzhou Jianle Fine Chemical Products Co., Ltd's FEI number is 3004578916.
What types of violations has Suzhou Jianle Fine Chemical Products Co., Ltd received?
Suzhou Jianle Fine Chemical Products Co., Ltd has been cited for 2 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 Suzhou Jianle Fine Chemical Products Co., Ltd come from?
All FDA import refusal data for Suzhou Jianle Fine Chemical Products 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.