SHENZHEN FRD SCIENCE & TECHNOLOG
⚠️ Moderate Risk
FEI: 3014272946 • Shenzhen City • CHINA
FEI Number
3014272946
Location
Shenzhen City
Country
CHINAAddress
Frd Building, No 8 Gao, Shenzhen City, , 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).
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 SHENZHEN FRD SCIENCE & TECHNOLOG's FDA import refusal history?
SHENZHEN FRD SCIENCE & TECHNOLOG (FEI: 3014272946) has 1 FDA import refusal record(s) in our database, spanning from 5/29/2018 to 5/29/2018.
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. SHENZHEN FRD SCIENCE & TECHNOLOG's FEI number is 3014272946.
What types of violations has SHENZHEN FRD SCIENCE & TECHNOLOG received?
SHENZHEN FRD SCIENCE & TECHNOLOG 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 SHENZHEN FRD SCIENCE & TECHNOLOG come from?
All FDA import refusal data for SHENZHEN FRD SCIENCE & TECHNOLOG 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.