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Primus Corporation dba Trinity Biotech

✅ Low Risk

FEI: 1931251 • Kansas City, MO • UNITED STATES

FEI

FEI Number

1931251

📍

Location

Kansas City, MO

🇺🇸
🏢

Address

4231 E 75th Ter, , Kansas City, MO, 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
2
Unique Violations
10/22/2007
Latest Refusal
10/22/2007
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
10/22/2007
78FKJFILTER, BLOOD, DIALYSIS
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Primus Corporation dba Trinity Biotech's FDA import refusal history?

Primus Corporation dba Trinity Biotech (FEI: 1931251) has 1 FDA import refusal record(s) in our database, spanning from 10/22/2007 to 10/22/2007.

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. Primus Corporation dba Trinity Biotech's FEI number is 1931251.

What types of violations has Primus Corporation dba Trinity Biotech received?

Primus Corporation dba Trinity Biotech 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 Primus Corporation dba Trinity Biotech come from?

All FDA import refusal data for Primus Corporation dba Trinity Biotech 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.