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•United States

Ensitevascular LLC, Overland Park, KS – FDA Inspections

Inspection records and compliance data for Ensitevascular LLC in Overland Park, Kansas. 1 FDA inspection on record, 1 Form 483, last inspected November 06, 2024.

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Company Profile

This profile covers Ensitevascular LLC based in Overland Park, Kansas, United States.

FDA Inspection History

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

Inspected November 6, 2024.

Most cited issue areas

  • Design control - no procedures1 inspection
  • Evaluation and Selection, Suppliers, Contractors, etc.1 inspection
  • Quality Audit/Reaudit - conducted1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
November 6, 2024NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1253833
FDA documents

Form 483s (1)

  • Form 483s · November 6, 2024
People (1)
Eric C. Fox
Person
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Keranetics Inc.
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LSI Solutions, Inc.
Company Information

Name

Ensitevascular LLC

FEI Number

3020031299

Address

10561 Barkley St Ste 610, Overland Park, Kansas 66212, United States

Country

United States

ID: f92b38d7-235a-49da-a080-761189214b62

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