WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD.
⚠️ High Risk
FEI: 3017710338 • Hwaseong, Gyeonggi • SOUTH KOREA
FEI Number
3017710338
Location
Hwaseong, Gyeonggi
Country
SOUTH KOREAAddress
44 Jeongnamsandan1-gil, Jeongnam-Myeon, Hwaseong, Gyeonggi, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/10/2023 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/23/2023 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/23/2023 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/24/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/24/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD.'s FDA import refusal history?
WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD. (FEI: 3017710338) has 5 FDA import refusal record(s) in our database, spanning from 5/24/2023 to 7/10/2023.
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. WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD.'s FEI number is 3017710338.
What types of violations has WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD. received?
WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD. 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 WELLMADE HOUSEHOLD & HEALTH CARE CO., LTD. come from?
All FDA import refusal data for WELLMADE HOUSEHOLD & HEALTH CARE CO., 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.