Guangzhou Hedy Tech. Co Ltd
✅ Low Risk
FEI: 3011476828 • Guangzhou • CHINA
FEI Number
3011476828
Location
Guangzhou
Country
CHINAAddress
4F Bldg A1 Shishe Ind Zone, , Guangzhou, , 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Guangzhou Hedy Tech. Co Ltd's FDA import refusal history?
Guangzhou Hedy Tech. Co Ltd (FEI: 3011476828) has 1 FDA import refusal record(s) in our database, spanning from 5/26/2015 to 5/26/2015.
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. Guangzhou Hedy Tech. Co Ltd's FEI number is 3011476828.
What types of violations has Guangzhou Hedy Tech. Co Ltd received?
Guangzhou Hedy Tech. 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 Guangzhou Hedy Tech. Co Ltd come from?
All FDA import refusal data for Guangzhou Hedy Tech. 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.