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Trewavis Surgical Instruments Pty Ltd., Bayswater, Australia – FDA Inspections

Inspection records and compliance data for Trewavis Surgical Instruments Pty Ltd. in Bayswater. 3 FDA inspections on record, 1 Form 483, last inspected January 22, 2025.

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Company Profile

This profile covers Trewavis Surgical Instruments Pty Ltd. based in Bayswater, Australia.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
1
Form 483s
1
Warning letters
0

First inspected February 7, 2017. Last inspected January 22, 2025.

Most cited issue areas

  • Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
  • Lack of or inadequate final acceptance procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
January 22, 2025NAIMedical Devices & Rad Health · Compliance: Devices1260936
August 17, 2022VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1177941
February 7, 2017VAIMedical Devices & Rad Health · Compliance: Devices1013187
FDA documents

Form 483s (1)

  • Form 483s · August 17, 2022
People (1)
Christopher S. Genther
Person
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Company Information

Name

Trewavis Surgical Instruments Pty Ltd.

FEI Number

3006795395

Address

21 Michellan Ct, Bayswater, Australia

Country

Australia

ID: 2985bcc9-0ba0-42ba-876b-e49655f4a3eb

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