LG HOUSEHOLD & HEALTH CARE LTD.
⚠️ High Risk
FEI: 3010486573 • Jongro, Seoul • SOUTH KOREA
FEI Number
3010486573
Location
Jongro, Seoul
Country
SOUTH KOREAAddress
58 Saemunan-Ro, , Jongro, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 MISB
The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2025 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/23/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/18/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/23/2024 | 55PP30SODIUM BENZOATE (PHARMACEUTIC NECESSITY - ANTIFUNGAL AGENT) | 472NO ENGLISH | Division of West Coast Imports (DWCI) |
| 10/16/2018 | 65LBL99PROTECTANT N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 65LBL99PROTECTANT N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 65LBL99PROTECTANT N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LG HOUSEHOLD & HEALTH CARE LTD.'s FDA import refusal history?
LG HOUSEHOLD & HEALTH CARE LTD. (FEI: 3010486573) has 7 FDA import refusal record(s) in our database, spanning from 10/16/2018 to 6/27/2025.
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 & HEALTH CARE LTD.'s FEI number is 3010486573.
What types of violations has LG HOUSEHOLD & HEALTH CARE LTD. received?
LG HOUSEHOLD & HEALTH CARE LTD. has been cited for 6 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 & HEALTH CARE LTD. come from?
All FDA import refusal data for LG HOUSEHOLD & HEALTH CARE LTD. 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.