P.T. Latexindo Tobaperkasa
⚠️ Moderate Risk
FEI: 3000983331 • Medan, Sumatera Utara • INDONESIA
FEI Number
3000983331
Location
Medan, Sumatera Utara
Country
INDONESIAAddress
Km. 11, Jln. Baja Raya; BINJAL, Medan, Sumatera Utara, 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 |
|---|---|---|---|
| 1/18/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 1/18/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 12/9/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Florida District Office (FLA-DO) |
| 3/10/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 9/26/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/10/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is P.T. Latexindo Tobaperkasa's FDA import refusal history?
P.T. Latexindo Tobaperkasa (FEI: 3000983331) has 6 FDA import refusal record(s) in our database, spanning from 7/10/2003 to 1/18/2011.
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. P.T. Latexindo Tobaperkasa's FEI number is 3000983331.
What types of violations has P.T. Latexindo Tobaperkasa received?
P.T. Latexindo Tobaperkasa 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 P.T. Latexindo Tobaperkasa come from?
All FDA import refusal data for P.T. Latexindo Tobaperkasa 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.