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•United States

Cogmedix, Inc., West Boylston, MA – FDA Inspections

Inspection records and compliance data for Cogmedix, Inc. in West Boylston, Massachusetts. 4 FDA inspections on record, last inspected April 11, 2024.

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Company Profile

This profile covers Cogmedix, Inc. based in West Boylston, Massachusetts, United States.

FDA Inspection History

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

First inspected April 21, 2011. Last inspected April 11, 2024.

Most cited issue areas

  • Lack of or inadequate procedures2 inspections
  • Evaluation of suppliers, contractors, etc., requirements1 inspection
  • Failure to report1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
April 11, 2024VAIMedical Devices & Rad Health · Radiation Control and Health Safety Act1235696
January 19, 2018Not classifiedMedical Devices & Rad Health1038648
May 31, 2013VAIMedical Devices & Rad Health · Compliance: Devices834006
April 21, 2011NAIMedical Devices & Rad Health · Compliance: Devices722907
FDA documents

Form 483s (2)

  • Form 483s · April 11, 2024
  • Form 483s · March 7, 2022
People (2)
John A. Sciacchitano
Person
Jeffrey J. Thibodeau
Person
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Company Information

Name

Cogmedix, Inc.

FEI Number

3007712511

Address

127 Hartwell St, West Boylston, Massachusetts 01583, United States

Country

United States

ID: d94764f2-2a76-4c03-bdeb-ed135912fe6c

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