Shijiazhuang Kegin Trading Co Ltd
⚠️ Moderate Risk
FEI: 3009761589 • Shijiahuang • CHINA
FEI Number
3009761589
Location
Shijiahuang
Country
CHINAAddress
148 Yuhua Road Room 1501 Block A, , Shijiahuang, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 Shijiazhuang Kegin Trading Co Ltd's FDA import refusal history?
Shijiazhuang Kegin Trading Co Ltd (FEI: 3009761589) has 2 FDA import refusal record(s) in our database, spanning from 10/4/2012 to 10/4/2012.
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. Shijiazhuang Kegin Trading Co Ltd's FEI number is 3009761589.
What types of violations has Shijiazhuang Kegin Trading Co Ltd received?
Shijiazhuang Kegin Trading Co Ltd has been cited for 4 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 Shijiazhuang Kegin Trading Co Ltd come from?
All FDA import refusal data for Shijiazhuang Kegin Trading 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.