FDA Inspection 1202812 — Pure Solutions, Inc.
The FDA completed an inspection of Pure Solutions, Inc. on April 13, 2023 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15866 | 21 CFR 111.75(a)(2)(ii)(E) | Documentation - quality control, review, approve supplier |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |