809138
Sundial Herbs and Herbal Products Enterprise — FEI 1000119548
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 15, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Bronx, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15883 | 21 CFR 111.75(i) | Corrective action plan |
| 16074 | 21 CFR 111.35(b)(4) | Records - equipment; calibrations, inspections, checks |