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K.CHANATHIP

⚠️ Moderate Risk

FEI: 3017355113 • Tak • THAILAND

FEI

FEI Number

3017355113

📍

Location

Tak

🇹🇭

Country

THAILAND
🏢

Address

2/9-10 Chidlom Road, T.Maesot , A.Maesot, Tak, , Thailand

Moderate Risk

FDA Import Risk Assessment

36.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
12/3/2020
Latest Refusal
12/3/2020
Earliest Refusal

Score Breakdown

Violation Severity
67.5×40%
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

752×

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).

4731×

LABELING

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

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
12/3/2020
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
473LABELING
483DRUG NAME
Division of Southeast Imports (DSEI)
12/3/2020
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/3/2020
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is K.CHANATHIP's FDA import refusal history?

K.CHANATHIP (FEI: 3017355113) has 3 FDA import refusal record(s) in our database, spanning from 12/3/2020 to 12/3/2020.

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. K.CHANATHIP's FEI number is 3017355113.

What types of violations has K.CHANATHIP received?

K.CHANATHIP 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 K.CHANATHIP come from?

All FDA import refusal data for K.CHANATHIP 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.