KooJoo Trading Company
⚠️ Moderate Risk
FEI: 3004562367 • Gyeongki-Do • SOUTH KOREA
FEI Number
3004562367
Location
Gyeongki-Do
Country
SOUTH KOREAAddress
116-7 Songma-li, Daegoj-myun, , Gimpo City, Gyeongki-Do, , 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2013 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 7/22/2013 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 290DE IMP GMP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is KooJoo Trading Company's FDA import refusal history?
KooJoo Trading Company (FEI: 3004562367) has 2 FDA import refusal record(s) in our database, spanning from 7/22/2013 to 10/4/2013.
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. KooJoo Trading Company's FEI number is 3004562367.
What types of violations has KooJoo Trading Company received?
KooJoo Trading Company has been cited for 1 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 KooJoo Trading Company come from?
All FDA import refusal data for KooJoo Trading Company 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.