Lg Household & Hea
⚠️ Moderate Risk
FEI: 3008849510 • Seoul, Seoul • SOUTH KOREA
FEI Number
3008849510
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
Shinmunno 2 Ga 92, , Seoul, 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
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).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/8/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 3260NO ENGLISH | Atlanta District Office (ATL-DO) |
| 8/2/2013 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/2/2013 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/2/2013 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/17/2012 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | New York District Office (NYK-DO) |
| 7/17/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lg Household & Hea's FDA import refusal history?
Lg Household & Hea (FEI: 3008849510) has 6 FDA import refusal record(s) in our database, spanning from 7/17/2012 to 8/8/2013.
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. Lg Household & Hea's FEI number is 3008849510.
What types of violations has Lg Household & Hea received?
Lg Household & Hea has been cited for 5 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 Lg Household & Hea come from?
All FDA import refusal data for Lg Household & Hea 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.