DRGEM CORPORATION
✅ Low Risk
FEI: 3006551157 • Gwangmyeong, Gyeonggi-Do • SOUTH KOREA
FEI Number
3006551157
Location
Gwangmyeong, Gyeonggi-Do
Country
SOUTH KOREAAddress
7F, E-B/D Gwangmyeong Techno-Park, 60 Haan-ro, Gwangmyeong, Gyeonggi-Do, South Korea
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
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2011 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | 278NO TAG | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is DRGEM CORPORATION's FDA import refusal history?
DRGEM CORPORATION (FEI: 3006551157) has 1 FDA import refusal record(s) in our database, spanning from 1/6/2011 to 1/6/2011.
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. DRGEM CORPORATION's FEI number is 3006551157.
What types of violations has DRGEM CORPORATION received?
DRGEM CORPORATION 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 DRGEM CORPORATION come from?
All FDA import refusal data for DRGEM CORPORATION 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.