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•United States

Scimedx Corporation, Dover, NJ – FDA Inspections

Inspection records and compliance data for Scimedx Corporation in Dover, New Jersey. 4 FDA inspections on record, last inspected October 05, 2018.

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Company Profile

This profile covers Scimedx Corporation based in Dover, New Jersey, United States.

FDA Inspection History

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

First inspected January 22, 2010. Last inspected October 5, 2018.

Most cited issue areas

  • Calibration documentation1 inspection
  • Not approved or obsolete document retrieval1 inspection
  • Training - Lack of or inadequate procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
October 5, 2018Not classifiedMedical Devices & Rad Health1116869
November 16, 2016NAIMedical Devices & Rad Health · Postmarket Assurance: Devices994636
November 30, 2012NAIMedical Devices & Rad Health · Compliance: Devices808267
January 22, 2010VAIMedical Devices & Rad Health · Compliance: Devices640388
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Caroline A. Glicksman, M.D.
Mirion Technologies (Capintec), Inc.
Company Information

Name

Scimedx Corporation

FEI Number

1000122189

Address

53 Richboynton Rd, Dover, New Jersey 07801, United States

Country

United States

ID: 3af76b35-630f-4920-b43a-1740b59adde4

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