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PRIMA CIPTA MANDIRI

⚠️ Moderate Risk

FEI: 3013035540 • BALI • INDONESIA

FEI

FEI Number

3013035540

📍

Location

BALI

🇮🇩

Country

INDONESIA
🏢

Address

53 DALUNG, , BALI, , Indonesia

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/30/2019
Latest Refusal
9/30/2019
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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.

Refusal History

DateProductViolationsDivision
9/30/2019
54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is PRIMA CIPTA MANDIRI's FDA import refusal history?

PRIMA CIPTA MANDIRI (FEI: 3013035540) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2019 to 9/30/2019.

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. PRIMA CIPTA MANDIRI's FEI number is 3013035540.

What types of violations has PRIMA CIPTA MANDIRI received?

PRIMA CIPTA MANDIRI 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 PRIMA CIPTA MANDIRI come from?

All FDA import refusal data for PRIMA CIPTA MANDIRI 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.