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Smiths Medical ASD, Inc.

⚠️ Moderate Risk

FEI: 1217052 • Keene, NH • UNITED STATES

FEI

FEI Number

1217052

📍

Location

Keene, NH

🇺🇸
🏢

Address

10 Bowman Dr, , Keene, NH, United States

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/13/2011
Latest Refusal
7/6/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

5082×

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
7/13/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
508NO 510(K)
Southwest Import District Office (SWI-DO)
7/6/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
508NO 510(K)
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Smiths Medical ASD, Inc.'s FDA import refusal history?

Smiths Medical ASD, Inc. (FEI: 1217052) has 2 FDA import refusal record(s) in our database, spanning from 7/6/2011 to 7/13/2011.

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. Smiths Medical ASD, Inc.'s FEI number is 1217052.

What types of violations has Smiths Medical ASD, Inc. received?

Smiths Medical ASD, 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 Smiths Medical ASD, Inc. come from?

All FDA import refusal data for Smiths Medical ASD, 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.