FDA Inspection 1230890 — Far East Summit LLC
The FDA completed an inspection of Far East Summit LLC on Feb 14, 2024 in Dexter, OR. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 14, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dexter, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15943 | 21 CFR 111.105(i) | QC required operations components packaging labels |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |