FDA Inspection 1288094 — Marine Minerals, Inc.
The FDA completed an inspection of Marine Minerals, Inc. on October 22, 2025 in Mesa, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mesa, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22815 | 21 CFR 111.8 | Written procedures - establish; personnel |
| 22827 | 21 CFR 111.16 | Written procedures - establish; cleaning |
| 22848 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22870 | 21 CFR 111.153 | Written procedures - establish; components |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |