Panasonic Latin America S A
⚠️ High Risk
FEI: 1000156157 • Barrio Colon, Panama Oeste • PANAMA
FEI
FEI Number
1000156157
📍
Location
Barrio Colon, Panama Oeste
🇵🇦
Country
PANAMA🏢
Address
La Chorrera, Apartado 7592, Barrio Colon, Panama Oeste, Panama
High Risk
FDA Import Risk Assessment
62.9
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
183
Total Refusals
5
Unique Violations
3/2/2009
Latest Refusal
11/14/2001
Earliest Refusal
Score Breakdown
Violation Severity
69.3×40%
Refusal Volume
83.9×30%
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
47179×
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.
1182×
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
3412×
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
4762×
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).
5081×
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2009 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 9/5/2008 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/5/2008 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 7/14/2008 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 7/2/2008 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/15/2008 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 11/5/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/5/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/5/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/5/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/5/2007 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/30/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 9/21/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 8/13/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 8/2/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 7/24/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 7/24/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 7/19/2007 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 5/30/2007 | 95RFWDVD, DVD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 5/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 5/16/2006 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | Florida District Office (FLA-DO) |
| 6/23/2005 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 5/24/2005 | 96M01MICROWAVE OVEN FOR FOOD PREPARATION | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/17/2005 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 47NON STD | Florida District Office (FLA-DO) |
| 2/15/2005 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/15/2005 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/3/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/3/2004 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 47NON STD | Division of Southeast Imports (DSEI) |
| 11/1/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 8/10/2004 | 97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE | 47NON STD | Division of Southeast Imports (DSEI) |
| 7/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 7/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 7/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 7/19/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 7/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 7/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 7/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 7/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 7/9/2004 | 96M01MICROWAVE OVEN FOR FOOD PREPARATION | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/25/2004 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 47NON STD | Florida District Office (FLA-DO) |
| 6/23/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 6/2/2004 | 96M01MICROWAVE OVEN FOR FOOD PREPARATION | 47NON STD | Florida District Office (FLA-DO) |
| 6/1/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 6/1/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 6/1/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 6/1/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 6/1/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 5/25/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/25/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/24/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/12/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/12/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/12/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/12/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/12/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 5/12/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 4/27/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 4/27/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/27/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/27/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/27/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/27/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/27/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/7/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 3/22/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/22/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 2/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Division of Southeast Imports (DSEI) |
| 2/4/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 1/29/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 96M01MICROWAVE OVEN FOR FOOD PREPARATION | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/28/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/23/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Division of Southeast Imports (DSEI) |
| 12/22/2003 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Florida District Office (FLA-DO) | |
| 12/22/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 96M01MICROWAVE OVEN FOR FOOD PREPARATION | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 96M01MICROWAVE OVEN FOR FOOD PREPARATION | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 96M01MICROWAVE OVEN FOR FOOD PREPARATION | 47NON STD | Florida District Office (FLA-DO) |
| 12/22/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Panasonic Latin America S A's FDA import refusal history?
Panasonic Latin America S A (FEI: 1000156157) has 183 FDA import refusal record(s) in our database, spanning from 11/14/2001 to 3/2/2009.
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. Panasonic Latin America S A's FEI number is 1000156157.
What types of violations has Panasonic Latin America S A received?
Panasonic Latin America S A has been cited for 5 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 Panasonic Latin America S A come from?
All FDA import refusal data for Panasonic Latin America 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.