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DEL MAR REYNOLDS MEDICAL INC

✅ Low Risk

FEI: 3013176660 • Irvine, CA • UNITED STATES

FEI

FEI Number

3013176660

📍

Location

Irvine, CA

🇺🇸
🏢

Address

13 Whatney, , Irvine, CA, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
1/13/2011
Latest Refusal
1/13/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
1/13/2011
74LOSSYSTEM, ECG ANALYSIS,
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is DEL MAR REYNOLDS MEDICAL INC's FDA import refusal history?

DEL MAR REYNOLDS MEDICAL INC (FEI: 3013176660) has 1 FDA import refusal record(s) in our database, spanning from 1/13/2011 to 1/13/2011.

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. DEL MAR REYNOLDS MEDICAL INC's FEI number is 3013176660.

What types of violations has DEL MAR REYNOLDS MEDICAL INC received?

DEL MAR REYNOLDS 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 DEL MAR REYNOLDS MEDICAL INC come from?

All FDA import refusal data for DEL MAR REYNOLDS 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.