FDA Inspection 809138 — Sundial Herbs And Herbal Products Enterprise
The FDA completed an inspection of Sundial Herbs And Herbal Products Enterprise on Nov 15, 2012 in Bronx, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 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 |