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Harmac Medical Products, Ltd.

⚠️ Moderate Risk

FEI: 3002468842 • Castlerea, Roscommon • IRELAND

FEI

FEI Number

3002468842

📍

Location

Castlerea, Roscommon

🇮🇪

Country

IRELAND
🏢

Address

Ida Business Park, , Castlerea, Roscommon, Ireland

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
11/18/2015
Latest Refusal
11/2/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
17.3×10%
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

1187×

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
11/18/2015
73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
118NOT LISTED
New Orleans District Office (NOL-DO)
11/18/2015
73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
118NOT LISTED
New Orleans District Office (NOL-DO)
11/2/2011
73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
118NOT LISTED
Atlanta District Office (ATL-DO)
11/2/2011
73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
118NOT LISTED
Atlanta District Office (ATL-DO)
11/2/2011
73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
118NOT LISTED
Atlanta District Office (ATL-DO)
11/2/2011
73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
118NOT LISTED
Atlanta District Office (ATL-DO)
11/2/2011
73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
118NOT LISTED
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Harmac Medical Products, Ltd.'s FDA import refusal history?

Harmac Medical Products, Ltd. (FEI: 3002468842) has 7 FDA import refusal record(s) in our database, spanning from 11/2/2011 to 11/18/2015.

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. Harmac Medical Products, Ltd.'s FEI number is 3002468842.

What types of violations has Harmac Medical Products, Ltd. received?

Harmac Medical Products, Ltd. 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 Harmac Medical Products, Ltd. come from?

All FDA import refusal data for Harmac Medical Products, Ltd. 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.