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Fujian Galle Commodity Co., Ltd

⚠️ Moderate Risk

FEI: 3007119796 • Zhangzhou • CHINA

FEI

FEI Number

3007119796

📍

Location

Zhangzhou

🇨🇳

Country

CHINA
🏢

Address

Xingtai Industril Park, Changtai, , Zhangzhou, , China

Moderate Risk

FDA Import Risk Assessment

36.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/12/2011
Latest Refusal
3/2/2011
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1972×

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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
12/12/2011
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/2/2011
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
473LABELING
New York District Office (NYK-DO)

Frequently Asked Questions

What is Fujian Galle Commodity Co., Ltd's FDA import refusal history?

Fujian Galle Commodity Co., Ltd (FEI: 3007119796) has 2 FDA import refusal record(s) in our database, spanning from 3/2/2011 to 12/12/2011.

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. Fujian Galle Commodity Co., Ltd's FEI number is 3007119796.

What types of violations has Fujian Galle Commodity Co., Ltd received?

Fujian Galle Commodity 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 Fujian Galle Commodity Co., Ltd come from?

All FDA import refusal data for Fujian Galle Commodity 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.