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Laboratorio Urena

✅ Low Risk

FEI: 3005274240 • Bugaba • PANAMA

FEI

FEI Number

3005274240

📍

Location

Bugaba

🇵🇦

Country

PANAMA
🏢

Address

Via Argentina Edif Balmoral, , Bugaba, , Panama

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
9/15/2005
Latest Refusal
9/15/2005
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
9/15/2005
31KYY99TEA, N.E.C.
260FALSE
473LABELING
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratorio Urena's FDA import refusal history?

Laboratorio Urena (FEI: 3005274240) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 9/15/2005.

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. Laboratorio Urena's FEI number is 3005274240.

What types of violations has Laboratorio Urena received?

Laboratorio Urena 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 Laboratorio Urena come from?

All FDA import refusal data for Laboratorio Urena 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.