Jean Moderns Ind Co Ltd
⚠️ Moderate Risk
FEI: 1000605680 • Taipei • TAIWAN
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2012 | 53CD99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 10/19/2006 | 79GFEBRUSH, DERMABRASION | Florida District Office (FLA-DO) | |
| 10/19/2006 | 79FTCLIGHT, ULTRAVIOLET, DERMATOLOGICAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Jean Moderns Ind Co Ltd's FDA import refusal history?
Jean Moderns Ind Co Ltd (FEI: 1000605680) has 3 FDA import refusal record(s) in our database, spanning from 10/19/2006 to 8/20/2012.
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. Jean Moderns Ind Co Ltd's FEI number is 1000605680.
What types of violations has Jean Moderns Ind Co Ltd received?
Jean Moderns Ind 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 Jean Moderns Ind Co Ltd come from?
All FDA import refusal data for Jean Moderns Ind 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.