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Amplion Clinical Communications, Inc., Nashville, TN – FDA Inspections

Inspection records and compliance data for Amplion Clinical Communications, Inc. in Nashville, Tennessee. 6 FDA inspections on record (1 OAI), 3 Form 483s, last inspected February 16, 2023.

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Company Profile

This profile covers Amplion Clinical Communications, Inc. based in Nashville, Tennessee, United States.

FDA Inspection History

FDA inspections
6
OAI
1
VAI
2
NAI
3
Form 483s
3
Warning letters
0

First inspected November 4, 2013. Last inspected February 16, 2023.

Most cited issue areas

  • Lack of or inadequate complaint procedures3 inspections
  • Lack of or inadequate procedures3 inspections
  • Design changes - Lack of or Inadequate Procedures2 inspections

FDA inspections (6)

DateResultFDA center(s)Insp. #
February 16, 2023NAIMedical Devices & Rad Health · Compliance: Devices1199005
September 8, 2021VAIMedical Devices & Rad Health · Compliance: Devices1151083
September 4, 2019NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1101295
September 7, 2017VAIMedical Devices & Rad Health · Compliance: Devices1024360
June 5, 2014NAIMedical Devices & Rad Health · Postmarket Assurance: Devices881285
November 4, 2013OAIMedical Devices & Rad Health · Compliance: Devices854307
FDA documents

Form 483s (3)

  • Form 483s · February 16, 2023
  • Form 483s · September 8, 2021
  • Form 483s · September 4, 2019
People (3)
Mary A. Millner
Person
Nikki S. Bryant
Person
Benjamin E. Bowen
Person
Related Companies (10)

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Thoratec LLC
American Contract Systems, Inc.
AMCO International Manufacturing & Design, Inc.
Footprint Medical, Inc.
Integra LifeSciences Corporation
Intuitive Surgical, Inc.
Company Information

Name

Amplion Clinical Communications, Inc.

FEI Number

3009164985

Address

632 Melrose Ave, Nashville, Tennessee 37211, United States

Country

United States

ID: 9de142e5-9171-405f-bf2c-890e2a0b5f93

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Contact
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Brooklyn, NY 11201
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Scranton, PA, 18503
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🇪🇺+48 532-447-507
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