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DePuy Orthopaedics, Inc.

⚠️ Moderate Risk

FEI: 1818910 • Warsaw, IN • UNITED STATES

FEI

FEI Number

1818910

📍

Location

Warsaw, IN

🇺🇸
🏢

Address

700 Orthopaedic Dr, , Warsaw, IN, United States

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
9/13/2006
Latest Refusal
9/13/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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
9/13/2006
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
New Orleans District Office (NOL-DO)
9/13/2006
79GDZHANDLE, SCALPEL
118NOT LISTED
New Orleans District Office (NOL-DO)
9/13/2006
87HWAIMPACTOR
118NOT LISTED
New Orleans District Office (NOL-DO)
9/13/2006
87HWBEXTRACTOR
118NOT LISTED
New Orleans District Office (NOL-DO)
9/13/2006
79FZXGUIDE, SURGICAL, INSTRUMENT
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is DePuy Orthopaedics, Inc.'s FDA import refusal history?

DePuy Orthopaedics, Inc. (FEI: 1818910) has 5 FDA import refusal record(s) in our database, spanning from 9/13/2006 to 9/13/2006.

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. DePuy Orthopaedics, Inc.'s FEI number is 1818910.

What types of violations has DePuy Orthopaedics, Inc. received?

DePuy Orthopaedics, 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 DePuy Orthopaedics, Inc. come from?

All FDA import refusal data for DePuy Orthopaedics, 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.