Dai Wha Corporation, Ltd.
⚠️ Moderate Risk
FEI: 1000128388 • Seoul • SOUTH KOREA
FEI Number
1000128388
Location
Seoul
Country
SOUTH KOREAAddress
Yeoksamng, Kangnam-Ku, 733-18 Dai Wha Building, 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
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2013 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) | |
| 7/12/2012 | 80FRNPUMP, INFUSION | Florida District Office (FLA-DO) | |
| 11/14/2011 | 79BWAUNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/14/2011 | 80FRNPUMP, INFUSION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/8/2011 | 80FRNPUMP, INFUSION | Seattle District Office (SEA-DO) | |
| 10/6/2005 | 80FRNPUMP, INFUSION | Florida District Office (FLA-DO) | |
| 11/3/2004 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) | |
| 11/3/2004 | 79BWAUNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 7/30/2003 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) | |
| 2/4/2003 | 79FRTUNIT, ISOLATION, SURGICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Dai Wha Corporation, Ltd.'s FDA import refusal history?
Dai Wha Corporation, Ltd. (FEI: 1000128388) has 10 FDA import refusal record(s) in our database, spanning from 2/4/2003 to 9/13/2013.
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. Dai Wha Corporation, Ltd.'s FEI number is 1000128388.
What types of violations has Dai Wha Corporation, Ltd. received?
Dai Wha Corporation, 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 Dai Wha Corporation, Ltd. come from?
All FDA import refusal data for Dai Wha Corporation, 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.