FDA Inspection 1292380 — KAEAEPAE BIOTECH
The FDA completed an inspection of KAEAEPAE BIOTECH on November 20, 2025 in Karjalohja. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 20, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Karjalohja (Finland)
Citations
| ID | CFR | Description |
|---|---|---|
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |