FDA Inspection 1333586 — Sundance Botanicals, LLC
The FDA completed an inspection of Sundance Botanicals, LLC on Aug 28, 2026 in La Porte, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 28, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- La Porte, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |