Shangrao Native Produce & Animal Byproducts Import & Export
⚠️ Moderate Risk
FEI: 3005379136 • Shanghai • CHINA
FEI Number
3005379136
Location
Shanghai
Country
CHINAAddress
No.39 Changning Road, , Shanghai, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 Shangrao Native Produce & Animal Byproducts Import & Export's FDA import refusal history?
Shangrao Native Produce & Animal Byproducts Import & Export (FEI: 3005379136) has 2 FDA import refusal record(s) in our database, spanning from 11/2/2005 to 11/2/2005.
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. Shangrao Native Produce & Animal Byproducts Import & Export's FEI number is 3005379136.
What types of violations has Shangrao Native Produce & Animal Byproducts Import & Export received?
Shangrao Native Produce & Animal Byproducts Import & Export 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 Shangrao Native Produce & Animal Byproducts Import & Export come from?
All FDA import refusal data for Shangrao Native Produce & Animal Byproducts Import & Export 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.