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Commonwealth Diagnostics International Inc., Salem, MA – FDA Inspections

Inspection records and compliance data for Commonwealth Diagnostics International Inc. in Salem, Massachusetts. 2 FDA inspections on record, last inspected June 25, 2015.

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Company Profile

This profile covers Commonwealth Diagnostics International Inc. based in Salem, Massachusetts, United States.

FDA Inspection History

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

First inspected March 15, 2012. Last inspected June 25, 2015.

Most cited issue areas

  • Lack of or inadequate complaint procedures2 inspections
  • Design validation acceptance criteria1 inspection
  • DHR content1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
June 25, 2015VAIMedical Devices & Rad Health · Compliance: Devices939364
March 15, 2012VAIMedical Devices & Rad Health · Compliance: Devices773983
FDA documents

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

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Company Information

Name

Commonwealth Diagnostics International Inc.

FEI Number

3009236726

Address

39 Norman St, Salem, Massachusetts 01970, United States

Country

United States

ID: 9792aed3-1904-4735-b017-81c6c02a553e

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