FDA Inspection 938168 — New Herb Health, LLC
The FDA completed an inspection of New Herb Health, LLC on August 13, 2015 in Mead, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 13, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mead, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15392 | 21 CFR 111.10(b)(4) | Jewelry and objects - remove |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |