SUZHOU SUGOU TRADING CO
✅ Low Risk
FEI: 3012747507 • Jiaxing • CHINA
FEI Number
3012747507
Location
Jiaxing
Country
CHINAAddress
# 601 Building 30 Jiazho, , Jiaxing, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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.
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).
Refusal History
Frequently Asked Questions
What is SUZHOU SUGOU TRADING CO's FDA import refusal history?
SUZHOU SUGOU TRADING CO (FEI: 3012747507) has 1 FDA import refusal record(s) in our database, spanning from 10/19/2016 to 10/19/2016.
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. SUZHOU SUGOU TRADING CO's FEI number is 3012747507.
What types of violations has SUZHOU SUGOU TRADING CO received?
SUZHOU SUGOU TRADING CO 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 SUZHOU SUGOU TRADING CO come from?
All FDA import refusal data for SUZHOU SUGOU TRADING CO 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.