Pt Haloni Jane
⚠️ Moderate Risk
FEI: 3004040517 • Tangerang, Jabotabek • INDONESIA
FEI Number
3004040517
Location
Tangerang, Jabotabek
Country
INDONESIAAddress
KM13.8 Cikupa, Jln. Setia Raya, Tangerang, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/25/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Philadelphia District Office (PHI-DO) |
| 5/25/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Philadelphia District Office (PHI-DO) |
| 5/25/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Philadelphia District Office (PHI-DO) |
| 5/25/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Philadelphia District Office (PHI-DO) |
| 3/28/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Philadelphia District Office (PHI-DO) |
| 3/12/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 3/12/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 8/12/2004 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pt Haloni Jane's FDA import refusal history?
Pt Haloni Jane (FEI: 3004040517) has 8 FDA import refusal record(s) in our database, spanning from 8/12/2004 to 5/25/2007.
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 Haloni Jane's FEI number is 3004040517.
What types of violations has Pt Haloni Jane received?
Pt Haloni Jane 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 Pt Haloni Jane come from?
All FDA import refusal data for Pt Haloni Jane 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.