FDA Inspection 1310630 — Wellnov Supplements LLC
The FDA completed an inspection of Wellnov Supplements LLC on April 2, 2026 in Chandler, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chandler, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15779 | 21 CFR 111.415(a) | Clean, sanitize - filling, packaging equipment |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |