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Pt Boga Karunia Dwitunggal

⚠️ Moderate Risk

FEI: 3005482749 • Taman Cibodas Tangerang • INDONESIA

FEI

FEI Number

3005482749

📍

Location

Taman Cibodas Tangerang

🇮🇩

Country

INDONESIA
🏢

Address

Komplek Dutamas, , Taman Cibodas Tangerang, , Indonesia

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
9/6/2007
Latest Refusal
9/6/2007
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

624×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

834×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
9/6/2007
37JCI03CHILI SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
9/6/2007
37JCI03CHILI SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
9/6/2007
37JCI03CHILI SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
9/6/2007
37JCI03CHILI SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Pt Boga Karunia Dwitunggal's FDA import refusal history?

Pt Boga Karunia Dwitunggal (FEI: 3005482749) has 4 FDA import refusal record(s) in our database, spanning from 9/6/2007 to 9/6/2007.

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 Boga Karunia Dwitunggal's FEI number is 3005482749.

What types of violations has Pt Boga Karunia Dwitunggal received?

Pt Boga Karunia Dwitunggal 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 Pt Boga Karunia Dwitunggal come from?

All FDA import refusal data for Pt Boga Karunia Dwitunggal 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.