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B. BRAUN DOMINICAN REPUBLIC INC.

⚠️ Moderate Risk

FEI: 3003767881 • Distrito Nacional, DO • DOMINICAN REPUBLIC

FEI

FEI Number

3003767881

📍

Location

Distrito Nacional, DO

🇩🇴
🏢

Address

Km. 22, Las Americas Highway, Zone Franca, Parque Las Americas, Santo Domingo, Distrito Nacional , DO, Dominican Republic

Moderate Risk

FDA Import Risk Assessment

33.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/23/2025
Latest Refusal
5/23/2025
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
87.0×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/23/2025
78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is B. BRAUN DOMINICAN REPUBLIC INC.'s FDA import refusal history?

B. BRAUN DOMINICAN REPUBLIC INC. (FEI: 3003767881) has 1 FDA import refusal record(s) in our database, spanning from 5/23/2025 to 5/23/2025.

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. B. BRAUN DOMINICAN REPUBLIC INC.'s FEI number is 3003767881.

What types of violations has B. BRAUN DOMINICAN REPUBLIC INC. received?

B. BRAUN DOMINICAN REPUBLIC INC. 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 B. BRAUN DOMINICAN REPUBLIC INC. come from?

All FDA import refusal data for B. BRAUN DOMINICAN REPUBLIC INC. 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.