VENOGEN BIOCHEMICALS
⚠️ High Risk
FEI: 3040092579 • Hong Kong • HONG KONG
FEI Number
3040092579
Location
Hong Kong
Country
HONG KONGAddress
70 Queens Rd 1104 Centr, , Hong Kong, , Hong Kong
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2025 | 54YIY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2025 | 61NAY99ANTI-DEPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/2/2025 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/20/2025 | 54KIY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2025 | 60BIZ99ACIDIFIER N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/7/2025 | 75PDAINVESTIGATIONAL USE ONLY - CLINICAL CHEMISTRY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/7/2025 | 63XBY99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VENOGEN BIOCHEMICALS's FDA import refusal history?
VENOGEN BIOCHEMICALS (FEI: 3040092579) has 8 FDA import refusal record(s) in our database, spanning from 11/3/2025 to 12/30/2025.
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. VENOGEN BIOCHEMICALS's FEI number is 3040092579.
What types of violations has VENOGEN BIOCHEMICALS received?
VENOGEN BIOCHEMICALS 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 VENOGEN BIOCHEMICALS come from?
All FDA import refusal data for VENOGEN BIOCHEMICALS 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.