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J&K Intl

⚠️ Moderate Risk

FEI: 3008565653 • Chacengcho • THAILAND

FEI

FEI Number

3008565653

📍

Location

Chacengcho

🇹🇭

Country

THAILAND
🏢

Address

3-2 Moo.1 Bangna-Trad 35 Km, , Chacengcho, , Thailand

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/17/2013
Latest Refusal
12/17/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

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
12/17/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
3260NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is J&K Intl's FDA import refusal history?

J&K Intl (FEI: 3008565653) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2013 to 12/17/2013.

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 Intl's FEI number is 3008565653.

What types of violations has J&K Intl received?

J&K Intl has been cited for 2 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 Intl come from?

All FDA import refusal data for J&K Intl 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.