CLP Cosmetic Co., Ltd
⚠️ Moderate Risk
FEI: 3016706332 • Bucheon, Gyeonggi • SOUTH KOREA
FEI Number
3016706332
Location
Bucheon, Gyeonggi
Country
SOUTH KOREAAddress
3 790 Pyeongcheon-Ro, , Bucheon, Gyeonggi, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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
Frequently Asked Questions
What is CLP Cosmetic Co., Ltd's FDA import refusal history?
CLP Cosmetic Co., Ltd (FEI: 3016706332) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2022 to 11/15/2022.
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. CLP Cosmetic Co., Ltd's FEI number is 3016706332.
What types of violations has CLP Cosmetic Co., Ltd received?
CLP Cosmetic Co., Ltd 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 CLP Cosmetic Co., Ltd come from?
All FDA import refusal data for CLP Cosmetic 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.