Chang Jo Int'L Co., Ltd
⚠️ Moderate Risk
FEI: 3006770240 • Incheon, INCHEON GWANGYEOGSIV • SOUTH KOREA
FEI Number
3006770240
Location
Incheon, INCHEON GWANGYEOGSIV
Country
SOUTH KOREAAddress
58-38, Chongchon-Dong , Bupyeong-Gu, , Incheon, INCHEON GWANGYEOGSIV, South Korea
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
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 9/22/2010 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 8/19/2010 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Chang Jo Int'L Co., Ltd's FDA import refusal history?
Chang Jo Int'L Co., Ltd (FEI: 3006770240) has 3 FDA import refusal record(s) in our database, spanning from 8/19/2010 to 10/7/2011.
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. Chang Jo Int'L Co., Ltd's FEI number is 3006770240.
What types of violations has Chang Jo Int'L Co., Ltd received?
Chang Jo Int'L 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 Chang Jo Int'L Co., Ltd come from?
All FDA import refusal data for Chang Jo Int'L 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.