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Shaanxi Keysun Bio-Tech Co. Ltd.

⚠️ Moderate Risk

FEI: 3013379283 • Renhe Town, Guangzhou • CHINA

FEI

FEI Number

3013379283

📍

Location

Renhe Town, Guangzhou

🇨🇳

Country

CHINA
🏢

Address

No. 25 Minghan Road, Mingxing Village, Renhe Town, Guangzhou, China

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/17/2017
Latest Refusal
4/17/2017
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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

1971×

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).

4711×

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.

4751×

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.

Refusal History

DateProductViolationsDivision
4/17/2017
53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
197COSM COLOR
471CSTIC LBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shaanxi Keysun Bio-Tech Co. Ltd.'s FDA import refusal history?

Shaanxi Keysun Bio-Tech Co. Ltd. (FEI: 3013379283) has 1 FDA import refusal record(s) in our database, spanning from 4/17/2017 to 4/17/2017.

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. Shaanxi Keysun Bio-Tech Co. Ltd.'s FEI number is 3013379283.

What types of violations has Shaanxi Keysun Bio-Tech Co. Ltd. received?

Shaanxi Keysun Bio-Tech 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 Shaanxi Keysun Bio-Tech Co. Ltd. come from?

All FDA import refusal data for Shaanxi Keysun Bio-Tech 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.