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J & K International Co.Ltd.

⚠️ Moderate Risk

FEI: 3007200190 • Chacheangtsout • THAILAND

FEI

FEI Number

3007200190

📍

Location

Chacheangtsout

🇹🇭

Country

THAILAND
🏢

Address

3/2 Moo 1 Toombol Pimpa Ampur Bangpakong, , Chacheangtsout, , Thailand

Moderate Risk

FDA Import Risk Assessment

29.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
7/21/2017
Latest Refusal
1/28/2010
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.7×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

29401×

COSM MISB

The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).

4731×

LABELING

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

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)
2940COSM MISB
Division of Southeast Imports (DSEI)
1/28/2010
66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
473LABELING
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is J & K International Co.Ltd.'s FDA import refusal history?

J & K International Co.Ltd. (FEI: 3007200190) has 2 FDA import refusal record(s) in our database, spanning from 1/28/2010 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. J & K International Co.Ltd.'s FEI number is 3007200190.

What types of violations has J & K International Co.Ltd. received?

J & K International 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 J & K International Co.Ltd. come from?

All FDA import refusal data for J & K International 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.