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Pt Gracindo Utama

⚠️ Moderate Risk

FEI: 3011459505 • Kec Tjj Priok • INDONESIA

FEI

FEI Number

3011459505

📍

Location

Kec Tjj Priok

🇮🇩

Country

INDONESIA
🏢

Address

Jl Dananu Sunter Selatan, Blok E No 5, , Kel Sunter Jaya, Kec Tjj Priok, , Indonesia

Moderate Risk

FDA Import Risk Assessment

39.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/20/2015
Latest Refusal
6/18/2015
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
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

162×

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.

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
11/20/2015
54Y99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
16DIRECTIONS
Cincinnati District Office (CIN-DO)
10/21/2015
53PY99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
Cincinnati District Office (CIN-DO)
6/18/2015
54Y99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
16DIRECTIONS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Pt Gracindo Utama's FDA import refusal history?

Pt Gracindo Utama (FEI: 3011459505) has 3 FDA import refusal record(s) in our database, spanning from 6/18/2015 to 11/20/2015.

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 Gracindo Utama's FEI number is 3011459505.

What types of violations has Pt Gracindo Utama received?

Pt Gracindo Utama 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 Gracindo Utama come from?

All FDA import refusal data for Pt Gracindo Utama 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.