FDA Inspection 855059 — Prime Herbs Corporation
The FDA completed an inspection of Prime Herbs Corporation on November 6, 2013 in Sunnyvale, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 6, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sunnyvale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3149 | 21 CFR 820.180 | Availability |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |