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Miami Express S.A.

⚠️ Moderate Risk

FEI: 3004154155 • Panama • PANAMA

FEI

FEI Number

3004154155

📍

Location

Panama

🇵🇦

Country

PANAMA
🏢

Address

Via Cincuentenario Ave 5ta Sur, , Panama, , Panama

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/14/2003
Latest Refusal
10/14/2003
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
10/14/2003
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Miami Express S.A.'s FDA import refusal history?

Miami Express S.A. (FEI: 3004154155) has 1 FDA import refusal record(s) in our database, spanning from 10/14/2003 to 10/14/2003.

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. Miami Express S.A.'s FEI number is 3004154155.

What types of violations has Miami Express S.A. received?

Miami Express 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 Miami Express S.A. come from?

All FDA import refusal data for Miami Express 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.