FDA Inspection 1071285 — Far East Summit LLC
The FDA completed an inspection of Far East Summit LLC on November 9, 2018 in Dexter, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dexter, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |