Wuhan Fortuna Chemical Co., Ltd.
⚠️ Moderate Risk
FEI: 2000037792 • Wuhan, Hubei • CHINA
FEI Number
2000037792
Location
Wuhan, Hubei
Country
CHINAAddress
Dengyue Mansion Room 403, 314 Xinhua Xiao Road, Wuhan, Hubei, 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).
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
Frequently Asked Questions
What is Wuhan Fortuna Chemical Co., Ltd.'s FDA import refusal history?
Wuhan Fortuna Chemical Co., Ltd. (FEI: 2000037792) has 2 FDA import refusal record(s) in our database, spanning from 10/21/2010 to 8/8/2025.
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. Wuhan Fortuna Chemical Co., Ltd.'s FEI number is 2000037792.
What types of violations has Wuhan Fortuna Chemical Co., Ltd. received?
Wuhan Fortuna Chemical Co., Ltd. has been cited for 2 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 Wuhan Fortuna Chemical Co., Ltd. come from?
All FDA import refusal data for Wuhan Fortuna 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.