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CR BARD

⚠️ Moderate Risk

FEI: 3017559894 • Moncks Corner, SC • UNITED STATES

FEI

FEI Number

3017559894

📍

Location

Moncks Corner, SC

🇺🇸
🏢

Address

428 Power House Rd, , Moncks Corner, SC, United States

Moderate Risk

FDA Import Risk Assessment

42.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
6/26/2017
Latest Refusal
6/14/2017
Earliest Refusal

Score Breakdown

Violation Severity
72.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

4794×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
6/26/2017
78KODCATHETER, UROLOGICAL
479DV QUALITY
Division of Southwest Imports (DSWI)
6/26/2017
78KODCATHETER, UROLOGICAL
479DV QUALITY
Division of Southwest Imports (DSWI)
6/26/2017
78KODCATHETER, UROLOGICAL
479DV QUALITY
Division of Southwest Imports (DSWI)
6/26/2017
78KODCATHETER, UROLOGICAL
479DV QUALITY
Division of Southwest Imports (DSWI)
6/14/2017
78KODCATHETER, UROLOGICAL
126FAILS STD
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is CR BARD's FDA import refusal history?

CR BARD (FEI: 3017559894) has 5 FDA import refusal record(s) in our database, spanning from 6/14/2017 to 6/26/2017.

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. CR BARD's FEI number is 3017559894.

What types of violations has CR BARD received?

CR BARD has been cited for 2 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 CR BARD come from?

All FDA import refusal data for CR BARD 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.