Aiwa Latinoamerica (Panama), S.A.
⚠️ Moderate Risk
FEI: 3002462943 • Panama • PANAMA
FEI Number
3002462943
Location
Panama
Country
PANAMAAddress
P.O. Box 55-0519 Paitilla, , Panama, , Panama
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/27/2002 | 97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 1/31/2002 | 97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 1/31/2002 | 97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 12/5/2001 | 97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 12/5/2001 | 97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Aiwa Latinoamerica (Panama), S.A.'s FDA import refusal history?
Aiwa Latinoamerica (Panama), S.A. (FEI: 3002462943) has 5 FDA import refusal record(s) in our database, spanning from 12/5/2001 to 3/27/2002.
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. Aiwa Latinoamerica (Panama), S.A.'s FEI number is 3002462943.
What types of violations has Aiwa Latinoamerica (Panama), S.A. received?
Aiwa Latinoamerica (Panama), S.A. 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 Aiwa Latinoamerica (Panama), S.A. come from?
All FDA import refusal data for Aiwa Latinoamerica (Panama), 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.