Johnson-Johnson Indonesia
⚠️ Moderate Risk
FEI: 3008742077 • Jakarta, Jabotabek • INDONESIA
FEI Number
3008742077
Location
Jakarta, Jabotabek
Country
INDONESIAAddress
Jln Wisma Jaya, , Jakarta, Jabotabek, Indonesia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2012 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/6/2012 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/6/2012 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2012 | 68CBY20ANTISEPTIC USED MORE THAN 1 SPECIES | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Johnson-Johnson Indonesia's FDA import refusal history?
Johnson-Johnson Indonesia (FEI: 3008742077) has 11 FDA import refusal record(s) in our database, spanning from 6/12/2012 to 9/6/2012.
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. Johnson-Johnson Indonesia's FEI number is 3008742077.
What types of violations has Johnson-Johnson Indonesia received?
Johnson-Johnson Indonesia 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 Johnson-Johnson Indonesia come from?
All FDA import refusal data for Johnson-Johnson 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.