FDA Inspection 832948 — Holistic Technologies, LLC
The FDA completed an inspection of Holistic Technologies, LLC on May 23, 2013 in Milton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Milton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |