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•United States

Diacor, Inc, Mount Pleasant, UT – FDA Inspections

Inspection records and compliance data for Diacor, Inc in Mount Pleasant, Utah. 4 FDA inspections on record, 1 Form 483, last inspected September 08, 2017.

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Company Profile

This profile covers Diacor, Inc based in Mount Pleasant, Utah, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
1
NAI
3
Form 483s
1
Warning letters
0

First inspected June 25, 2009. Last inspected September 8, 2017.

Most cited issue areas

  • Complaints1 inspection
  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Design Validation - Risk analysis not performed/inadequate1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
September 8, 2017NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1024795
June 19, 2013NAIMedical Devices & Rad Health · Postmarket Assurance: Devices836648
June 17, 2010NAIMedical Devices & Rad Health · Radiation Control and Health Safety Act671010
June 25, 2009VAIMedical Devices & Rad Health · Compliance: Devices592352
FDA documents

Form 483s (1)

  • Form 483s · October 3, 2019
People (1)
James R. Montero
Person
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Company Information

Name

Diacor, Inc

FEI Number

1721113

Address

1236 S Airstrip Ln, Mount Pleasant, Utah 84647-2208, United States

Country

United States

ID: 11688ab9-29f4-4edd-9d07-82c11bec238a

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