992726
The Herbalist Inc — FEI 3004393766
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 4, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |