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Pioneer International Latin Am

⚠️ Moderate Risk

FEI: 1000596992 • Panama, Rep De Panama • PANAMA

FEI

FEI Number

1000596992

📍

Location

Panama, Rep De Panama

🇵🇦

Country

PANAMA
🏢

Address

Zona Libre De Colon, , Panama, Rep De Panama, Panama

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/6/2001
Latest Refusal
12/6/2001
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

472×

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
12/6/2001
97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
47NON STD
Florida District Office (FLA-DO)
12/6/2001
97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
47NON STD
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Pioneer International Latin Am's FDA import refusal history?

Pioneer International Latin Am (FEI: 1000596992) has 2 FDA import refusal record(s) in our database, spanning from 12/6/2001 to 12/6/2001.

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 Am's FEI number is 1000596992.

What types of violations has Pioneer International Latin Am received?

Pioneer International Latin Am 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 Pioneer International Latin Am come from?

All FDA import refusal data for Pioneer International Latin Am 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.