FDA Inspection 1242225 — Sun Breeze Inc
The FDA completed an inspection of Sun Breeze Inc on Jun 21, 2024 in Central Point, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 21, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Central Point, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15950 | 21 CFR 111.110(b) | Quality control operations - tests, examinations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |