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Pt Buana Adhi Gemilang

⚠️ Moderate Risk

FEI: 3012300057 • Surabaya, Jawa Timur • INDONESIA

FEI

FEI Number

3012300057

📍

Location

Surabaya, Jawa Timur

🇮🇩

Country

INDONESIA
🏢

Address

Jln. Kalijudan 304, , Surabaya, Jawa Timur, Indonesia

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
4/16/2018
Latest Refusal
4/16/2018
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

163×

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.

Refusal History

DateProductViolationsDivision
4/16/2018
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
16DIRECTIONS
Division of Southeast Imports (DSEI)
4/16/2018
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
16DIRECTIONS
Division of Southeast Imports (DSEI)
4/16/2018
54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
16DIRECTIONS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Pt Buana Adhi Gemilang's FDA import refusal history?

Pt Buana Adhi Gemilang (FEI: 3012300057) has 3 FDA import refusal record(s) in our database, spanning from 4/16/2018 to 4/16/2018.

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. Pt Buana Adhi Gemilang's FEI number is 3012300057.

What types of violations has Pt Buana Adhi Gemilang received?

Pt Buana Adhi Gemilang has been cited for 1 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 Pt Buana Adhi Gemilang come from?

All FDA import refusal data for Pt Buana Adhi Gemilang 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.