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•United States

Panoramic Corp., Fort Wayne, IN – FDA Inspections

Inspection records and compliance data for Panoramic Corp. in Fort Wayne, Indiana. 4 FDA inspections on record (2 OAI), 1 Form 483, last inspected August 07, 2019.

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Company Profile

This profile covers Panoramic Corp. based in Fort Wayne, Indiana, United States.

FDA Inspection History

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

First inspected August 13, 2009. Last inspected August 7, 2019.

Most cited issue areas

  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Design Validation - Risk analysis not performed/inadequate1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
August 7, 2019NAIMedical Devices & Rad Health · Radiation Control and Health Safety Act1098901
September 7, 2016OAIMedical Devices & Rad Health · Compliance: Devices985833
April 24, 2015OAIMedical Devices & Rad Health · Postmarket Assurance: Devices923678
August 13, 2009NAIMedical Devices & Rad Health · Radiation Control and Health Safety Act605215
FDA documents

Form 483s (1)

  • Form 483s · August 7, 2019
People (1)
David J. Gasparovich
Person
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SleepNet Corporation
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Company Information

Name

Panoramic Corp.

FEI Number

1832462

Address

4321 Goshen Rd, Fort Wayne, Indiana 46818, United States

Country

United States

ID: 737d4017-26bf-4229-92de-eedfc6773452

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