FDA Inspection 1274478 — ActivePure Manufacturing LLC, A Wholly Owned Subsidiary Of ActivePure Technologies LLC
The FDA completed an inspection of ActivePure Manufacturing LLC, A Wholly Owned Subsidiary Of ActivePure Technologies LLC on Jun 18, 2025 in Bristol, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bristol, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |