ImportRefusal LogoImportRefusal

Xiamen Dancoly Cosmetics Co., Ltd

⚠️ Moderate Risk

FEI: 3012107000 • Xiamen, Fujian • CHINA

FEI

FEI Number

3012107000

📍

Location

Xiamen, Fujian

🇨🇳

Country

CHINA
🏢

Address

4F, No. 266, Tong'an Park, Tong'an Concentrated Industry Zone, Xiamen, Fujian, China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
11/1/2010
Latest Refusal
11/1/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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

DateProductViolationsDivision
11/1/2010
55QP51ALCOHOL (PHARMACEUTIC NECESSITY - SOLVENT)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Xiamen Dancoly Cosmetics Co., Ltd's FDA import refusal history?

Xiamen Dancoly Cosmetics Co., Ltd (FEI: 3012107000) has 1 FDA import refusal record(s) in our database, spanning from 11/1/2010 to 11/1/2010.

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. Xiamen Dancoly Cosmetics Co., Ltd's FEI number is 3012107000.

What types of violations has Xiamen Dancoly Cosmetics Co., Ltd received?

Xiamen Dancoly Cosmetics Co., Ltd has been cited for 1 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 Xiamen Dancoly Cosmetics Co., Ltd come from?

All FDA import refusal data for Xiamen Dancoly Cosmetics 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.