FDA Inspection 1267193 — Far East Summit LLC
The FDA completed an inspection of Far East Summit LLC on April 18, 2025 in Dexter, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 18, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dexter, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12721 | 21 CFR 1.234 | Registration not updated |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15579 | 21 CFR 111.155(c)(1) | Components - representative samples |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 16004 | 21 CFR 111.130(b) | Quality control operations -returned dietary supplement; salvage, redistribution |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22819 | 21 CFR 111.12 | Personnel - qualifications |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22863 | 21 CFR 111.110 | Quality control - Laboratory control processes; production, process control |
| 22865 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22897 | 21 CFR 111.325(b) | Make and keep records - laboratory operations |