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Calox De Costa Rica S.A.

⚠️ Moderate Risk

FEI: 3007177479 • San Josesan Jose • COSTA RICA

FEI

FEI Number

3007177479

📍

Location

San Josesan Jose

🇨🇷

Country

COSTA RICA
🏢

Address

50 Metros Sur, Cruce Colima Tib?s, , San Josesan Jose, , Costa Rica

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/13/2008
Latest Refusal
11/13/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/13/2008
65PCA02SILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Calox De Costa Rica S.A.'s FDA import refusal history?

Calox De Costa Rica S.A. (FEI: 3007177479) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2008 to 11/13/2008.

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. Calox De Costa Rica S.A.'s FEI number is 3007177479.

What types of violations has Calox De Costa Rica S.A. received?

Calox De Costa Rica S.A. 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 Calox De Costa Rica S.A. come from?

All FDA import refusal data for Calox De Costa Rica 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.