FDA Inspection 1110682 — Morningstar Minerals LLC
The FDA completed an inspection of Morningstar Minerals LLC on November 21, 2019 in Farmington, NM. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 21, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Farmington, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15976 | 21 CFR 111.123 | Quality control operations - master, batch, manufacturing |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |