New & New Co., Ltd.
⚠️ Moderate Risk
FEI: 3009692276 • Cheonan, Chungcheongnam • SOUTH KOREA
FEI Number
3009692276
Location
Cheonan, Chungcheongnam
Country
SOUTH KOREAAddress
85 Baekseokgongdan1-Ro, Seobuk District, Cheonan, Chungcheongnam, 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
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).
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 |
|---|---|---|---|
| 10/17/2022 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2016 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) | |
| 5/19/2016 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Cincinnati District Office (CIN-DO) | |
| 4/20/2016 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) | |
| 4/20/2016 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is New & New Co., Ltd.'s FDA import refusal history?
New & New Co., Ltd. (FEI: 3009692276) has 5 FDA import refusal record(s) in our database, spanning from 4/20/2016 to 10/17/2022.
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. New & New Co., Ltd.'s FEI number is 3009692276.
What types of violations has New & New Co., Ltd. received?
New & New Co., Ltd. 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 New & New Co., Ltd. come from?
All FDA import refusal data for New & New Co., 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.