Unidus Corporation
⚠️ Moderate Risk
FEI: 3003196200 • Seoul • SOUTH KOREA
FEI Number
3003196200
Location
Seoul
Country
SOUTH KOREAAddress
Seokyung Bldg., 51 Bang-I Dong, Songpa-Ku, Seoul, , 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2014 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/5/2014 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/5/2014 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/5/2014 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/5/2014 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/5/2014 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/15/2014 | 85HISCONDOM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/15/2014 | 85HISCONDOM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/15/2014 | 85HISCONDOM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/15/2014 | 85HISCONDOM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/15/2014 | 85HISCONDOM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/15/2014 | 85HISCONDOM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 6/17/2014 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 1/2/2014 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 6/26/2013 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Unidus Corporation's FDA import refusal history?
Unidus Corporation (FEI: 3003196200) has 20 FDA import refusal record(s) in our database, spanning from 6/26/2013 to 12/5/2014.
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. Unidus Corporation's FEI number is 3003196200.
What types of violations has Unidus Corporation received?
Unidus Corporation has been cited for 3 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 Unidus Corporation come from?
All FDA import refusal data for Unidus 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.