FDA Inspection 1300854 — Akeso Health Sciences, LLC
The FDA completed an inspection of Akeso Health Sciences, LLC on February 2, 2026 in Westlake Village, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Westlake Village, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 22860 | 21 CFR 111.103 | Written procedures - follow; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22909 | 21 CFR 111.503 | Written procedures - follow; returned dietary supplements |
| 22916 | 21 CFR 111.570(b)(2)(ii) | Record - product complaint; written record information |