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•United States

Inventex Medical, Niles, IL – FDA Inspections

Inspection records and compliance data for Inventex Medical in Niles, Illinois. 2 FDA inspections on record, 2 Form 483s, last inspected September 13, 2023.

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Company Profile

This profile covers Inventex Medical based in Niles, Illinois, United States.

FDA Inspection History

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

First inspected July 27, 2017. Last inspected September 13, 2023.

Most cited issue areas

  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Documentation1 inspection
  • Document review, approval by designated individual1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
September 13, 2023NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1217698
July 27, 2017VAIMedical Devices & Rad Health · Compliance: Devices1019463
FDA documents

Form 483s (1)

  • Form 483s · September 13, 2023
People (1)
Nydia E. Colon
Person
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Company Information

Name

Inventex Medical

FEI Number

3009495876

Address

7415 N Melvina Ave, Niles, Illinois 60714, United States

Country

United States

ID: 78ca6456-a93e-47cb-9e0f-2af0fdbad057

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