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Tyco Healthcare Group LP (dba: Covidien)

⚠️ Moderate Risk

FEI: 1310379 • Watertown, NY • UNITED STATES

FEI

FEI Number

1310379

📍

Location

Watertown, NY

🇺🇸
🏢

Address

98.6 Faichney Drive, , Watertown, NY, 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
2/22/2010
Latest Refusal
2/22/2010
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
2/22/2010
80FLLTHERMOMETER, ELECTRONIC, CLINICAL
479DV QUALITY
New York District Office (NYK-DO)

Frequently Asked Questions

What is Tyco Healthcare Group LP (dba: Covidien)'s FDA import refusal history?

Tyco Healthcare Group LP (dba: Covidien) (FEI: 1310379) has 1 FDA import refusal record(s) in our database, spanning from 2/22/2010 to 2/22/2010.

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. Tyco Healthcare Group LP (dba: Covidien)'s FEI number is 1310379.

What types of violations has Tyco Healthcare Group LP (dba: Covidien) received?

Tyco Healthcare Group LP (dba: Covidien) 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 Tyco Healthcare Group LP (dba: Covidien) come from?

All FDA import refusal data for Tyco Healthcare Group LP (dba: Covidien) 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.