Pioneer International Latin American S.A
⚠️ High Risk
FEI: 1000155426 • Panama • PANAMA
High Risk
FDA Import Risk Assessment
59.6
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
120
Total Refusals
2
Unique Violations
6/3/2008
Latest Refusal
10/4/2001
Earliest Refusal
Score Breakdown
Violation Severity
66.2×40%
Refusal Volume
77.1×30%
Recency
0.0×20%
Frequency
100.0×10%
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
4774×
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
47646×
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2008 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/3/2008 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/3/2008 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/3/2008 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/3/2008 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/4/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/4/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/4/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/4/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/4/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/13/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/13/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/13/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/13/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/13/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/11/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 4/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 4/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 4/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 4/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 4/11/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 3/16/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 3/16/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 3/16/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 3/16/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 3/16/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 3/16/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 2/1/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/1/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/1/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/1/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/1/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/1/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/1/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/17/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 1/17/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 1/17/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 1/17/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 1/17/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 1/17/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 1/17/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 1/17/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 11/17/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 10/16/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 9/11/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 8/24/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/24/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/1/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 8/1/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/29/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 6/29/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Pioneer International Latin American S.A's FDA import refusal history?
Pioneer International Latin American S.A (FEI: 1000155426) has 120 FDA import refusal record(s) in our database, spanning from 10/4/2001 to 6/3/2008.
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. Pioneer International Latin American S.A's FEI number is 1000155426.
What types of violations has Pioneer International Latin American S.A received?
Pioneer International Latin American S.A 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 Pioneer International Latin American S.A come from?
All FDA import refusal data for Pioneer International Latin American S.A 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.