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Mandiri Bersama

⚠️ Moderate Risk

FEI: 3009533122 • Pontianak, Kalimantan Barat • INDONESIA

FEI

FEI Number

3009533122

📍

Location

Pontianak, Kalimantan Barat

🇮🇩

Country

INDONESIA
🏢

Address

Jln. Adisucipto 26, , Pontianak, Kalimantan Barat, Indonesia

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/21/2012
Latest Refusal
6/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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.

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
6/21/2012
53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Mandiri Bersama's FDA import refusal history?

Mandiri Bersama (FEI: 3009533122) has 1 FDA import refusal record(s) in our database, spanning from 6/21/2012 to 6/21/2012.

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. Mandiri Bersama's FEI number is 3009533122.

What types of violations has Mandiri Bersama received?

Mandiri Bersama 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 Mandiri Bersama come from?

All FDA import refusal data for Mandiri Bersama 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.