SHANGTOU HAICHAOXING TRADING COLTD
⚠️ Moderate Risk
FEI: 3023589401 • Shantou • CHINA
FEI Number
3023589401
Location
Shantou
Country
CHINAAddress
Rom 603 Kin Hwa Cheongbuilding Hengshan, , Shantou, , 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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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.
Refusal History
Frequently Asked Questions
What is SHANGTOU HAICHAOXING TRADING COLTD's FDA import refusal history?
SHANGTOU HAICHAOXING TRADING COLTD (FEI: 3023589401) has 1 FDA import refusal record(s) in our database, spanning from 9/16/2022 to 9/16/2022.
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. SHANGTOU HAICHAOXING TRADING COLTD's FEI number is 3023589401.
What types of violations has SHANGTOU HAICHAOXING TRADING COLTD received?
SHANGTOU HAICHAOXING TRADING COLTD 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 SHANGTOU HAICHAOXING TRADING COLTD come from?
All FDA import refusal data for SHANGTOU HAICHAOXING TRADING COLTD 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.