Amorepacific
⚠️ Moderate Risk
FEI: 3003851819 • Yongsan District, Seoul • SOUTH KOREA
FEI Number
3003851819
Location
Yongsan District, Seoul
Country
SOUTH KOREAAddress
100 Hangang-Daero, , Yongsan District, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2017 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 12/22/2004 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 12/7/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/15/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Amorepacific's FDA import refusal history?
Amorepacific (FEI: 3003851819) has 4 FDA import refusal record(s) in our database, spanning from 6/15/2004 to 12/29/2017.
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. Amorepacific's FEI number is 3003851819.
What types of violations has Amorepacific received?
Amorepacific has been cited for 3 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 Amorepacific come from?
All FDA import refusal data for Amorepacific 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.