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Irvine Biomedical Inc, a St. Jude Medical Co.

⚠️ Moderate Risk

FEI: 1000519796 • Irvine, CA • UNITED STATES

FEI

FEI Number

1000519796

📍

Location

Irvine, CA

🇺🇸
🏢

Address

2375 And 2382 Morse Ave, , Irvine, CA, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/5/2013
Latest Refusal
4/5/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
4/5/2013
74OADCATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
476NO REGISTR
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Irvine Biomedical Inc, a St. Jude Medical Co.'s FDA import refusal history?

Irvine Biomedical Inc, a St. Jude Medical Co. (FEI: 1000519796) has 1 FDA import refusal record(s) in our database, spanning from 4/5/2013 to 4/5/2013.

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. Irvine Biomedical Inc, a St. Jude Medical Co.'s FEI number is 1000519796.

What types of violations has Irvine Biomedical Inc, a St. Jude Medical Co. received?

Irvine Biomedical Inc, a St. Jude Medical Co. 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 Irvine Biomedical Inc, a St. Jude Medical Co. come from?

All FDA import refusal data for Irvine Biomedical Inc, a St. Jude Medical Co. 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.