FDA Inspection 1244271 — PuroVite Inc.
The FDA completed an inspection of PuroVite Inc. on Dec 23, 2024 in Doral, FL. 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). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 23, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 22835 | 21 CFR 111.25 | Equipment - follow written procedures |
| 22840 | 21 CFR 111.35(b) | Make and keep records - equipment and utensils |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22915 | 21 CFR 111.570(b) | Records - written procedures; product complaint |