FDA Inspection 1274447 — AMI Newco, LLC
The FDA completed an inspection of AMI Newco, LLC on Jun 20, 2025 in Carson City, NV. 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). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 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 |