FDA Inspection 1256512 — Eclectic Institute Inc
The FDA completed an inspection of Eclectic Institute Inc on December 13, 2024 in Gresham, OR. 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
- December 13, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gresham, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 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 |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |