Pure Oxygen Korea
⚠️ Moderate Risk
FEI: 3004946589 • Seoul • SOUTH KOREA
FEI Number
3004946589
Location
Seoul
Country
SOUTH KOREAAddress
792-4 Bangbaebon-D, , 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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 11/13/2006 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/13/2006 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/13/2006 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/13/2006 | 53LB99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 3/24/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/24/2006 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pure Oxygen Korea's FDA import refusal history?
Pure Oxygen Korea (FEI: 3004946589) has 6 FDA import refusal record(s) in our database, spanning from 3/24/2006 to 11/13/2006.
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. Pure Oxygen Korea's FEI number is 3004946589.
What types of violations has Pure Oxygen Korea received?
Pure Oxygen Korea 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 Pure Oxygen Korea come from?
All FDA import refusal data for Pure Oxygen Korea 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.