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JOHNSON AND JOHNSON ID MEDICAL DIVISION

⚠️ High Risk

FEI: 3035983887 • Jakarta Selatan, Dki Jakarta • INDONESIA

FEI

FEI Number

3035983887

📍

Location

Jakarta Selatan, Dki Jakarta

🇮🇩

Country

INDONESIA
🏢

Address

K-Link Tower Ll12, Jl Jent Gatot Subroto Ka, V 59a, Jakarta Selatan, Dki Jakarta, Indonesia

High Risk

FDA Import Risk Assessment

59.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
2
Unique Violations
10/31/2025
Latest Refusal
10/31/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
96.0×20%
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

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

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
10/31/2025
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is JOHNSON AND JOHNSON ID MEDICAL DIVISION's FDA import refusal history?

JOHNSON AND JOHNSON ID MEDICAL DIVISION (FEI: 3035983887) has 1 FDA import refusal record(s) in our database, spanning from 10/31/2025 to 10/31/2025.

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. JOHNSON AND JOHNSON ID MEDICAL DIVISION's FEI number is 3035983887.

What types of violations has JOHNSON AND JOHNSON ID MEDICAL DIVISION received?

JOHNSON AND JOHNSON ID MEDICAL DIVISION 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 JOHNSON AND JOHNSON ID MEDICAL DIVISION come from?

All FDA import refusal data for JOHNSON AND JOHNSON ID MEDICAL DIVISION 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.