FDA Inspection 1280669 — Earthley Wellness
The FDA completed an inspection of Earthley Wellness on September 5, 2025 in Columbus, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 22823 | 21 CFR 111.15(b) | Physical plant - clean and sanitary |
| 22878 | 21 CFR 111.160(e) | Labels - contamination, deterioration, mix-up |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22894 | 21 CFR 111.315(b) | Sampling plans; establish, follow |