ImportRefusal LogoImportRefusal

PT. ECOLAB INTERNATIONAL INDONESIA

⚠️ Moderate Risk

FEI: 3029464437 • Bogor, Jabotabek • INDONESIA

FEI

FEI Number

3029464437

📍

Location

Bogor, Jabotabek

🇮🇩

Country

INDONESIA
🏢

Address

Jalan Pahlawan Desa Karangasem Timur Citeureup, , Bogor, Jabotabek, Indonesia

Moderate Risk

FDA Import Risk Assessment

43.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/1/2023
Latest Refusal
11/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
55.6×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
11/1/2023
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is PT. ECOLAB INTERNATIONAL INDONESIA's FDA import refusal history?

PT. ECOLAB INTERNATIONAL INDONESIA (FEI: 3029464437) has 1 FDA import refusal record(s) in our database, spanning from 11/1/2023 to 11/1/2023.

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. ECOLAB INTERNATIONAL INDONESIA's FEI number is 3029464437.

What types of violations has PT. ECOLAB INTERNATIONAL INDONESIA received?

PT. ECOLAB INTERNATIONAL INDONESIA 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. ECOLAB INTERNATIONAL INDONESIA come from?

All FDA import refusal data for PT. ECOLAB INTERNATIONAL INDONESIA 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.