Ups/Kaf
⚠️ High Risk
FEI: 1000460924 • Seoul • SOUTH KOREA
FEI Number
1000460924
Location
Seoul
Country
SOUTH KOREAAddress
Unknown Street, , Seoul, , 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2005 | 62CCK41MINOXIDIL (ANTI-HYPERTENSIVE) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 64XCK07TRETINOIN (KERATOLYTIC) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 64RCK99HORMONE N.E.C. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 60CCK23ISOPROTERENOL HCL (ADRENERGIC) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 54CFK99PROTEIN N.E.C. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/27/2005 | 63NCK04DEXPANTHENOL (CHOLINERGIC) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ups/Kaf's FDA import refusal history?
Ups/Kaf (FEI: 1000460924) has 12 FDA import refusal record(s) in our database, spanning from 5/27/2005 to 5/27/2005.
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. Ups/Kaf's FEI number is 1000460924.
What types of violations has Ups/Kaf received?
Ups/Kaf 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 Ups/Kaf come from?
All FDA import refusal data for Ups/Kaf 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.