Mukunghwa Co.
⚠️ Moderate Risk
FEI: 3003801379 • Korea • SOUTH KOREA
FEI Number
3003801379
Location
Korea
Country
SOUTH KOREAAddress
521-10 Ha Dan Dongsaha Gu, , Busan, Korea, , 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
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).
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
Frequently Asked Questions
What is Mukunghwa Co.'s FDA import refusal history?
Mukunghwa Co. (FEI: 3003801379) has 1 FDA import refusal record(s) in our database, spanning from 5/13/2003 to 5/13/2003.
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. Mukunghwa Co.'s FEI number is 3003801379.
What types of violations has Mukunghwa Co. received?
Mukunghwa Co. 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 Mukunghwa Co. come from?
All FDA import refusal data for Mukunghwa Co. 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.