FDA Inspection
Advanced Machine, IncAdvanced Machine, Inc – FDA Inspection, Apr 18, 2025
Record Details
This FDA Inspection record concerns Advanced Machine, Inc, with an inspection on April 18, 2025, issued by the New Orleans District Office, covering medical devices & rad health.
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ID · 88f4d0a8-a552-48de-bf6e-af4deb33b41a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1267545
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.180Availability
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Other FDA inspections of Advanced Machine, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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