FDA Inspection 1274447 — AMI Newco, LLC dba Aloha Medicinals
The FDA completed an inspection of AMI Newco, LLC dba Aloha Medicinals on June 20, 2025 in Carson City, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Carson City, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |