Dalian Fusheng Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 3004901481 • Dalian, Liaoning • CHINA
FEI Number
3004901481
Location
Dalian, Liaoning
Country
CHINAAddress
No. 5 Tieshan Mid-Road, Economictec. Zon, , Dalian, Liaoning, 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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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
Frequently Asked Questions
What is Dalian Fusheng Pharmaceutical Co., Ltd's FDA import refusal history?
Dalian Fusheng Pharmaceutical Co., Ltd (FEI: 3004901481) has 1 FDA import refusal record(s) in our database, spanning from 5/13/2019 to 5/13/2019.
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. Dalian Fusheng Pharmaceutical Co., Ltd's FEI number is 3004901481.
What types of violations has Dalian Fusheng Pharmaceutical Co., Ltd received?
Dalian Fusheng Pharmaceutical Co., Ltd 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 Dalian Fusheng Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Dalian Fusheng Pharmaceutical 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.