Fujian Genohope Biotech Ltd
⚠️ High Risk
FEI: 3025263427 • Putian, Fujian • CHINA
FEI Number
3025263427
Location
Putian, Fujian
Country
CHINAAddress
No. 288 Renyang, Binglun Village, Hushi Town,, , Xiuyu District, Putian, Fujian, 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
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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/28/2025 | 61PCT74TIRZEPATIDE (ANTI-DIABETIC) | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 5/28/2025 | 61PCT74TIRZEPATIDE (ANTI-DIABETIC) | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 2/28/2025 | 61PCT74TIRZEPATIDE (ANTI-DIABETIC) | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 2/28/2025 | 61PCT74TIRZEPATIDE (ANTI-DIABETIC) | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 2/28/2025 | 61PCT74TIRZEPATIDE (ANTI-DIABETIC) | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 11/4/2024 | 61PBY74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 11/4/2024 | 61PBY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 10/28/2024 | 61PCS72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 10/28/2024 | 61PCS74TIRZEPATIDE (ANTI-DIABETIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Fujian Genohope Biotech Ltd's FDA import refusal history?
Fujian Genohope Biotech Ltd (FEI: 3025263427) has 9 FDA import refusal record(s) in our database, spanning from 10/28/2024 to 5/28/2025.
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. Fujian Genohope Biotech Ltd's FEI number is 3025263427.
What types of violations has Fujian Genohope Biotech Ltd received?
Fujian Genohope Biotech Ltd 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 Fujian Genohope Biotech Ltd come from?
All FDA import refusal data for Fujian Genohope Biotech 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.