ImportRefusal LogoImportRefusal

Covidien, LP

⚠️ Moderate Risk

FEI: 1650158 • Commerce, TX • UNITED STATES

FEI

FEI Number

1650158

📍

Location

Commerce, TX

🇺🇸
🏢

Address

400 Maple St, , Commerce, TX, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/31/2015
Latest Refusal
3/31/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

4791×

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.

Refusal History

DateProductViolationsDivision
3/31/2015
80FMFSYRINGE, PISTON
479DV QUALITY
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Covidien, LP's FDA import refusal history?

Covidien, LP (FEI: 1650158) has 1 FDA import refusal record(s) in our database, spanning from 3/31/2015 to 3/31/2015.

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. Covidien, LP's FEI number is 1650158.

What types of violations has Covidien, LP received?

Covidien, LP 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 Covidien, LP come from?

All FDA import refusal data for Covidien, LP 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.