White Medical Ind., Inc.
⚠️ High Risk
FEI: 1000551437 • Ulsan • SOUTH KOREA
FEI Number
1000551437
Location
Ulsan
Country
SOUTH KOREAAddress
1-14, Eunhyun-Ri, Ungchon-Myun, Ulju-Gun, Ulsan, , South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2003 | 79KGXTAPE AND BANDAGE, ADHESIVE | 2800POSS N/STR | Los Angeles District Office (LOS-DO) |
| 11/20/2003 | 79MXETAPE AND BANDAGE, ADHESIVE (WITH DISINFECTANT) | 2800POSS N/STR | Los Angeles District Office (LOS-DO) |
| 11/20/2003 | 79KGXTAPE AND BANDAGE, ADHESIVE | 2800POSS N/STR | Los Angeles District Office (LOS-DO) |
| 11/20/2003 | 79KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Los Angeles District Office (LOS-DO) |
| 5/20/2003 | 80FQMBANDAGE, ELASTIC | 2800POSS N/STR | New York District Office (NYK-DO) |
| 5/2/2003 | 80FQMBANDAGE, ELASTIC | 2800POSS N/STR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is White Medical Ind., Inc.'s FDA import refusal history?
White Medical Ind., Inc. (FEI: 1000551437) has 6 FDA import refusal record(s) in our database, spanning from 5/2/2003 to 11/20/2003.
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. White Medical Ind., Inc.'s FEI number is 1000551437.
What types of violations has White Medical Ind., Inc. received?
White Medical Ind., Inc. has been cited for 2 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 White Medical Ind., Inc. come from?
All FDA import refusal data for White Medical Ind., Inc. 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.