FDA Inspection 1003225 — Sundial Herbs and Herbal Products Enterprise
The FDA completed an inspection of Sundial Herbs and Herbal Products Enterprise on February 17, 2017 in Bronx, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
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 |