FDA Inspection
Trewavis Surgical Instruments Pty Ltd.Trewavis Surgical Instruments Pty Ltd. – FDA Inspection, Aug 17, 2022
Record Details
This FDA Inspection record concerns Trewavis Surgical Instruments Pty Ltd., with an inspection on August 17, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 17, 2022
- Product Type
- Devices
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ID · 2a8412ad-3622-43d3-a4cb-59c51c76ac1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1177941
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Trewavis Surgical Instruments Pty Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Trewavis Surgical Instruments Pty Ltd.
- FDA Inspection 1260936 - 2025-01-22
- FDA Inspection 1013187 - 2017-02-07
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