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CV BERKAY JAYA

⚠️ Moderate Risk

FEI: 3015170819 • Medan • INDONESIA

FEI

FEI Number

3015170819

📍

Location

Medan

🇮🇩

Country

INDONESIA
🏢

Address

8 Kel Titi Kuning Ke 12, , Medan, , Indonesia

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/11/2019
Latest Refusal
4/11/2019
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
4/11/2019
54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
260FALSE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CV BERKAY JAYA's FDA import refusal history?

CV BERKAY JAYA (FEI: 3015170819) has 1 FDA import refusal record(s) in our database, spanning from 4/11/2019 to 4/11/2019.

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. CV BERKAY JAYA's FEI number is 3015170819.

What types of violations has CV BERKAY JAYA received?

CV BERKAY JAYA 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 CV BERKAY JAYA come from?

All FDA import refusal data for CV BERKAY JAYA 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.