FDA Inspection 1300754 — Pure Solutions, Inc.
The FDA completed an inspection of Pure Solutions, Inc. on January 30, 2026 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15411 | 21 CFR 111.14(b)(2) | Personnel - records - training date, type, persons |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 22823 | 21 CFR 111.15(b) | Physical plant - clean and sanitary |
| 22826 | 21 CFR 111.15(k) | Sanitation supervisor |
| 22829 | 21 CFR 111.20(c) | Physical plant - prevent mix-ups, contamination |
| 22840 | 21 CFR 111.35(b) | Make and keep records - equipment and utensils |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22854 | 21 CFR 111.83(b) | Reserve sample - container-closure system |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22894 | 21 CFR 111.315(b) | Sampling plans; establish, follow |