794193
Healthy Spirit, LLC — FEI 2523141
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |