Yuhan Kimberly Chungju Mill
⚠️ Moderate Risk
FEI: 3010808341 • Chungju, Chungcheongbuk • SOUTH KOREA
FEI Number
3010808341
Location
Chungju, Chungcheongbuk
Country
SOUTH KOREAAddress
Yuhankimbeolli(Ju), 312 Cheomdansaneop-Ro; Daesowon-Myeon, Chungju, Chungcheongbuk, 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).
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 |
|---|---|---|---|
| 8/15/2016 | 85HHDPAD, MENSTRUAL, UNSCENTED | Atlanta District Office (ATL-DO) | |
| 8/15/2016 | 85HHDPAD, MENSTRUAL, UNSCENTED | Atlanta District Office (ATL-DO) | |
| 8/15/2016 | 85HHDPAD, MENSTRUAL, UNSCENTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Yuhan Kimberly Chungju Mill's FDA import refusal history?
Yuhan Kimberly Chungju Mill (FEI: 3010808341) has 3 FDA import refusal record(s) in our database, spanning from 8/15/2016 to 8/15/2016.
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. Yuhan Kimberly Chungju Mill's FEI number is 3010808341.
What types of violations has Yuhan Kimberly Chungju Mill received?
Yuhan Kimberly Chungju Mill 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 Yuhan Kimberly Chungju Mill come from?
All FDA import refusal data for Yuhan Kimberly Chungju Mill 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.