FDA Inspection
American Australian Medical, Inc.American Australian Medical, Inc. – FDA Inspection, Mar 7, 2018
Record Details
This FDA Inspection record concerns American Australian Medical, Inc., with an inspection on March 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c17f59e2-d575-4038-87f9-bc3a8c2ba745
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1043558
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of American Australian Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Australian Medical, Inc.
- FDA Inspection 1198665 - 2023-02-23
- FDA Inspection 1116629 - 2020-01-30
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