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Punto Rojo SA

✅ Low Risk

FEI: 1000212279 • Alajuela • COSTA RICA

FEI

FEI Number

1000212279

📍

Location

Alajuela

🇨🇷

Country

COSTA RICA
🏢

Address

Tribunales De Justicia Alajuela, Metros Norte 200, Alajuela, , Costa Rica

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/15/2009
Latest Refusal
9/15/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
9/15/2009
53LB01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Punto Rojo SA's FDA import refusal history?

Punto Rojo SA (FEI: 1000212279) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2009 to 9/15/2009.

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. Punto Rojo SA's FEI number is 1000212279.

What types of violations has Punto Rojo SA received?

Punto Rojo SA 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 Punto Rojo SA come from?

All FDA import refusal data for Punto Rojo SA 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.