ImportRefusal LogoImportRefusal

Disfarmaco S.R.L.

⚠️ Moderate Risk

FEI: 3012950856 • Santa Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3012950856

📍

Location

Santa Domingo

🇩🇴
🏢

Address

Calle 5 ESQ Calle 20 Villa Aura, Carretera De Manoguayabo, Santa Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

34.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/16/2025
Latest Refusal
7/16/2025
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
90.0×20%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
7/16/2025
62GCY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
472NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Disfarmaco S.R.L.'s FDA import refusal history?

Disfarmaco S.R.L. (FEI: 3012950856) has 1 FDA import refusal record(s) in our database, spanning from 7/16/2025 to 7/16/2025.

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. Disfarmaco S.R.L.'s FEI number is 3012950856.

What types of violations has Disfarmaco S.R.L. received?

Disfarmaco S.R.L. 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 Disfarmaco S.R.L. come from?

All FDA import refusal data for Disfarmaco S.R.L. 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.