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Ken En Cosmetics Industrial Co. Ltd.

⚠️ Moderate Risk

FEI: 3005278095 • Huizhou, Guangdong • CHINA

FEI

FEI Number

3005278095

📍

Location

Huizhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Jimadi, Boluoxian, Huizhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

40.5
LowModerateHighCritical

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

Statistics

6
Total Refusals
4
Unique Violations
5/30/2007
Latest Refusal
5/17/2007
Earliest Refusal

Score Breakdown

Violation Severity
62.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1974×

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).

4713×

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.

4753×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
5/30/2007
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
475COSMETLBLG
New York District Office (NYK-DO)
5/30/2007
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
475COSMETLBLG
New York District Office (NYK-DO)
5/24/2007
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
11UNSAFE COL
475COSMETLBLG
New York District Office (NYK-DO)
5/17/2007
53DD02PERFUMES (FRAGRANCE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
5/17/2007
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
471CSTIC LBLG
New York District Office (NYK-DO)
5/17/2007
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
471CSTIC LBLG
New York District Office (NYK-DO)

Frequently Asked Questions

What is Ken En Cosmetics Industrial Co. Ltd.'s FDA import refusal history?

Ken En Cosmetics Industrial Co. Ltd. (FEI: 3005278095) has 6 FDA import refusal record(s) in our database, spanning from 5/17/2007 to 5/30/2007.

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. Ken En Cosmetics Industrial Co. Ltd.'s FEI number is 3005278095.

What types of violations has Ken En Cosmetics Industrial Co. Ltd. received?

Ken En Cosmetics Industrial Co. Ltd. has been cited for 4 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 Ken En Cosmetics Industrial Co. Ltd. come from?

All FDA import refusal data for Ken En Cosmetics Industrial 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.