HENAN EXTEND TRADING CO
⚠️ Moderate Risk
FEI: 3013170378 • HENAN • 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
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).
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2017 | 54CIR01L-ALANINE (PROTEIN) | Division of Southeast Imports (DSEI) | |
| 7/24/2017 | 75JNBNINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 5/9/2017 | 54CYR01L-ALANINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2017 | 54CBZ01L-ALANINE (PROTEIN) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is HENAN EXTEND TRADING CO's FDA import refusal history?
HENAN EXTEND TRADING CO (FEI: 3013170378) has 4 FDA import refusal record(s) in our database, spanning from 2/23/2017 to 7/31/2017.
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. HENAN EXTEND TRADING CO's FEI number is 3013170378.
What types of violations has HENAN EXTEND TRADING CO received?
HENAN EXTEND TRADING CO has been cited for 4 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 HENAN EXTEND TRADING CO come from?
All FDA import refusal data for HENAN EXTEND TRADING CO 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.