FDA Inspection 1152545 — Oregons Wild Harvest Inc
The FDA completed an inspection of Oregons Wild Harvest Inc on September 24, 2021 in Redmond, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 24, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Redmond, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15707 | 21 CFR 111.325(a) | Laboratory operations: readily available |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 16079 | 21 CFR 111.35(b)(5) | Records - backup files, data |