FDA Inspection 1161233 — Morningstar Minerals LLC
The FDA completed an inspection of Morningstar Minerals LLC on January 21, 2022 in Farmington, NM. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 21, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Farmington, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |