HENAN EXTEND TRADING COMPANY
⚠️ High Risk
FEI: 3013157048 • Zhengzhou • CHINA
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2020 | 63XIK83MANNITOL (DIAGNOSTIC AID) (DRUGS) | Division of Southeast Imports (DSEI) | |
| 4/25/2019 | 54YIY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/7/2018 | 66VAP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/15/2017 | 56FYZ99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2017 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 54CYZ08L-GLUTAMINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 54CYZ08L-GLUTAMINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2017 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2017 | 54CDZ01L-ALANINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2017 | 54CDZ01L-ALANINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HENAN EXTEND TRADING COMPANY's FDA import refusal history?
HENAN EXTEND TRADING COMPANY (FEI: 3013157048) has 21 FDA import refusal record(s) in our database, spanning from 3/17/2017 to 3/23/2020.
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 COMPANY's FEI number is 3013157048.
What types of violations has HENAN EXTEND TRADING COMPANY received?
HENAN EXTEND TRADING COMPANY has been cited for 8 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 COMPANY come from?
All FDA import refusal data for HENAN EXTEND TRADING COMPANY 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.