1003225
Sundial Herbs and Herbal Products Enterprise — FEI 1000119548
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 17, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bronx, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 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 |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |