FDA Inspection 936729 — Eclectic Institute Inc
The FDA completed an inspection of Eclectic Institute Inc on July 31, 2015 in Gresham, OR. 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
- July 31, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gresham, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15389 | 21 CFR 111.10(b)(1) | Outer garments |
| 15399 | 21 CFR 111.10(b)(9) | Contamination - extraneous materials |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15460 | 21 CFR 111.20(d)(1)(ii) | Physical plant - fixture |
| 15465 | 21 CFR 111.20(d)(2) | Air blowing equipment |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 15940 | 21 CFR 111.105(h) | Quality control - production, process control |