FDA Inspection 1239743 — Mineral Resources International, Incorporated
The FDA completed an inspection of Mineral Resources International, Incorporated on May 20, 2024 in Ogden, UT. 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 20, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15579 | 21 CFR 111.155(c)(1) | Components - representative samples |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15946 | 21 CFR 111.105(i) | QC - required operations returned dietary supplements |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16085 | 21 CFR 111.75(c)(3) | Specifications met limits on contamination ; basis |