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B. Braun Medical, Inc.

⚠️ Moderate Risk

FEI: 2523676 • Allentown, PA • UNITED STATES

FEI

FEI Number

2523676

📍

Location

Allentown, PA

🇺🇸
🏢

Address

901 Marcon Blvd, , Allentown, PA, United States

Moderate Risk

FDA Import Risk Assessment

37.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/11/2023
Latest Refusal
1/11/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
26.0×20%
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

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
1/11/2023
80FPASET, ADMINISTRATION, INTRAVASCULAR
2480RXPERSONAL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is B. Braun Medical, Inc.'s FDA import refusal history?

B. Braun Medical, Inc. (FEI: 2523676) has 1 FDA import refusal record(s) in our database, spanning from 1/11/2023 to 1/11/2023.

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 Medical, Inc.'s FEI number is 2523676.

What types of violations has B. Braun Medical, Inc. received?

B. Braun Medical, 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 Medical, Inc. come from?

All FDA import refusal data for B. Braun Medical, 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.