FDA Inspection 840439 — Eclectic Institute Inc
The FDA completed an inspection of Eclectic Institute Inc on June 20, 2013 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
- June 20, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gresham, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15677 | 21 CFR 111.315(b)(1) | Sampling plans; components |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15883 | 21 CFR 111.75(i) | Corrective action plan |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |