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KATEVANICH INDUSTRY CO LTD

⚠️ Moderate Risk

FEI: 3013000828 • Bang Khun Thian, Bangkok • THAILAND

FEI

FEI Number

3013000828

📍

Location

Bang Khun Thian, Bangkok

🇹🇭

Country

THAILAND
🏢

Address

329 Sakae Ngam, Samae D, , Bang Khun Thian, Bangkok, Thailand

Moderate Risk

FDA Import Risk Assessment

28.2
LowModerateHighCritical

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

Statistics

3
Total Refusals
5
Unique Violations
7/21/2017
Latest Refusal
7/21/2017
Earliest Refusal

Score Breakdown

Violation Severity
46.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4733×

LABELING

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

4752×

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.

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.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

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
7/21/2017
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
473LABELING
475COSMETLBLG
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/21/2017
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
473LABELING
474COSMETLBLG
Division of Southeast Imports (DSEI)
7/21/2017
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
473LABELING
475COSMETLBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KATEVANICH INDUSTRY CO LTD's FDA import refusal history?

KATEVANICH INDUSTRY CO LTD (FEI: 3013000828) has 3 FDA import refusal record(s) in our database, spanning from 7/21/2017 to 7/21/2017.

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. KATEVANICH INDUSTRY CO LTD's FEI number is 3013000828.

What types of violations has KATEVANICH INDUSTRY CO LTD received?

KATEVANICH INDUSTRY CO LTD has been cited for 5 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 KATEVANICH INDUSTRY CO LTD come from?

All FDA import refusal data for KATEVANICH INDUSTRY 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.