FDA Inspection 1273893 — Bodymune Inc
The FDA completed an inspection of Bodymune Inc on June 26, 2025 in Kent, WA. 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
- June 26, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kent, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22844 | 21 CFR 111.70(c)(1) | In-process specification |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22860 | 21 CFR 111.103 | Written procedures - follow; quality control operations |
| 22871 | 21 CFR 111.153 | Written procedures - follow; components |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22912 | 21 CFR 111.560(a) | Product complaint - qualified person review & investigate |