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Aiwa Latinoamerica Panama) S.A.

⚠️ Moderate Risk

FEI: 1000378440 • Paitilla, Panama • PANAMA

FEI

FEI Number

1000378440

📍

Location

Paitilla, Panama

🇵🇦

Country

PANAMA
🏢

Address

P.O.Box 55-519, , Paitilla, Panama, Panama

Moderate Risk

FDA Import Risk Assessment

47.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

12
Total Refusals
2
Unique Violations
5/22/2002
Latest Refusal
10/25/2001
Earliest Refusal

Score Breakdown

Violation Severity
62.9×40%
Refusal Volume
41.3×30%
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

47612×

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).

475×

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

DateProductViolationsDivision
5/22/2002
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Southwest Import District Office (SWI-DO)
5/22/2002
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Southwest Import District Office (SWI-DO)
5/22/2002
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Southwest Import District Office (SWI-DO)
5/22/2002
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Southwest Import District Office (SWI-DO)
11/6/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
476NO REGISTR
Southwest Import District Office (SWI-DO)
11/6/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
476NO REGISTR
Southwest Import District Office (SWI-DO)
10/31/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
476NO REGISTR
Southwest Import District Office (SWI-DO)
10/31/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
476NO REGISTR
Southwest Import District Office (SWI-DO)
10/31/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
476NO REGISTR
Southwest Import District Office (SWI-DO)
10/25/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Southwest Import District Office (SWI-DO)
10/25/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Southwest Import District Office (SWI-DO)
10/25/2001
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Aiwa Latinoamerica Panama) S.A.'s FDA import refusal history?

Aiwa Latinoamerica Panama) S.A. (FEI: 1000378440) has 12 FDA import refusal record(s) in our database, spanning from 10/25/2001 to 5/22/2002.

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 1000378440.

What types of violations has Aiwa Latinoamerica Panama) S.A. received?

Aiwa Latinoamerica Panama) 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 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.