FDA Inspection 1265353 — Preventics Inc.
The FDA completed an inspection of Preventics Inc. on Apr 18, 2025 in Scottsdale, AZ. 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). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 18, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |
| 22812 | 21 CFR 111.453 | Written procedures - follow; holding and distribution |
| 22835 | 21 CFR 111.25 | Equipment - follow written procedures |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22848 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 22860 | 21 CFR 111.103 | Written procedures - follow; quality control operations |
| 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 |
| 22909 | 21 CFR 111.503 | Written procedures - follow; returned dietary supplements |
| 22915 | 21 CFR 111.570(b) | Records - written procedures; product complaint |
| 22916 | 21 CFR 111.570(b)(2)(ii) | Record - product complaint; written record information |