FDA Inspection 1267545 — Advanced Machine, Inc
The FDA completed an inspection of Advanced Machine, Inc on April 18, 2025 in Winchester, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Winchester, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |