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•United States

Nutek Orthopaedics, Inc., Fort Lauderdale, FL – FDA Inspections

Inspection records and compliance data for Nutek Orthopaedics, Inc. in Fort Lauderdale, Florida. 5 FDA inspections on record, 2 Form 483s, last inspected November 19, 2024.

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Company Profile

This profile covers Nutek Orthopaedics, Inc. based in Fort Lauderdale, Florida, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
1
NAI
4
Form 483s
2
Warning letters
0

First inspected November 4, 2011. Last inspected November 19, 2024.

Most cited issue areas

  • Lack of System for Event Evaluations2 inspections
  • Procedures not adequately established or maintained2 inspections
  • Purchasing controls, Lack of or inadequate procedures2 inspections

FDA inspections (5)

DateResultFDA center(s)Insp. #
November 19, 2024NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1254551
March 9, 2023NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1199695
January 4, 2018NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1036749
September 12, 2014VAIMedical Devices & Rad Health · Compliance: Devices895261
November 4, 2011NAIMedical Devices & Rad Health · Postmarket Assurance: Devices753056
FDA documents

Form 483s (1)

  • Form 483s · November 19, 2024
People (1)
Ebony D. Sanon
Person
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Company Information

Name

Nutek Orthopaedics, Inc.

FEI Number

3005893246

Address

641 SW 3rd Ave, Fort Lauderdale, Florida 33315, United States

Country

United States

ID: fe93f8bb-c176-4700-b8e2-47e32ba4da78

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