Kaiyuan Hengtai Chemical Co. Ltd
⚠️ Moderate Risk
FEI: 3008275093 • Kaiyuan, Liaoning • CHINA
FEI Number
3008275093
Location
Kaiyuan, Liaoning
Country
CHINAAddress
NO. 18 Yihe Road, , Kaiyuan, Liaoning, 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
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).
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.
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
Refusal History
Frequently Asked Questions
What is Kaiyuan Hengtai Chemical Co. Ltd's FDA import refusal history?
Kaiyuan Hengtai Chemical Co. Ltd (FEI: 3008275093) has 2 FDA import refusal record(s) in our database, spanning from 1/23/2006 to 3/3/2011.
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. Kaiyuan Hengtai Chemical Co. Ltd's FEI number is 3008275093.
What types of violations has Kaiyuan Hengtai Chemical Co. Ltd received?
Kaiyuan Hengtai Chemical 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 Kaiyuan Hengtai Chemical Co. Ltd come from?
All FDA import refusal data for Kaiyuan Hengtai 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.