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•United States

Anewmed Corporation, Tucker, GA – FDA Inspections

Inspection records and compliance data for Anewmed Corporation in Tucker, Georgia. 2 FDA inspections on record, 2 Form 483s, last inspected June 28, 2018.

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Company Profile

This profile covers Anewmed Corporation based in Tucker, Georgia, United States.

FDA Inspection History

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

First inspected October 18, 2016. Last inspected June 28, 2018.

Most cited issue areas

  • Design control - no procedures1 inspection
  • Lack of or inadequate final acceptance procedures1 inspection
  • Lack of or inadequate In-process acceptance procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
June 28, 2018NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1057908
October 18, 2016VAIMedical Devices & Rad Health · Compliance: Devices993047
FDA documents

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

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Georgia State University IRB #1
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Company Information

Name

Anewmed Corporation

FEI Number

3009711423

Address

2177 Flintstone Dr Ste O, Tucker, Georgia 30084, United States

Country

United States

ID: 23f66c0f-3994-4b65-a9b3-7f4e0bd7fe0f

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