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•United States

Kennedy, Philip R., Duluth, GA – FDA Inspections

Inspection records and compliance data for Kennedy, Philip R. in Duluth, Georgia. 2 FDA inspections on record (2 OAI), 1 warning letter, last inspected October 16, 2019.

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Company Profile

This profile covers Kennedy, Philip R. based in Duluth, Georgia, United States.

FDA Inspection History

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

First inspected May 29, 2009. Last inspected October 16, 2019.

Most cited issue areas

  • Investigator device accountability inadequate2 inspections
  • No financial disclosure info in investigator agreement2 inspections
  • Sponsor evaluation rpt not timely, distributed2 inspections

FDA inspections (2)

DateResultFDA center(s)Insp. #
October 16, 2019OAIMedical Devices & Rad Health · Bioresearch Monitoring1106571
May 29, 2009OAIMedical Devices & Rad Health · Bioresearch Monitoring603567
FDA documents

Form 483s (1)

  • Form 483s · October 16, 2019

Warning Letters (1)

  • Warning Letters · October 16, 2019
People (3)
Vanessa E. Coulter
Person
Sereen G. Morgan-Murray
Person
Soma Kalb
Person
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Hemosphere, Inc. (A CryoLife, Inc. Company)
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Company Information

Name

Kennedy, Philip R.

FEI Number

3007184242

Address

3400 Mcclure Bridge Rd Ste D402, Duluth, Georgia 30096, United States

Country

United States

ID: 7b46aa3d-fbf5-4657-9013-65abb06f4bfe

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