FDA Inspection 875238 — Sunset Natural Products Inc.
The FDA completed an inspection of Sunset Natural Products Inc. on April 10, 2014 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 10, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12720 | 21 CFR 1.225 | Not registered |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15756 | 21 CFR 111.205(c) | Master manufacturing record: electronic |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 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 |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |
| 908 | 21 CFR 123.6(d) | Signed and dated |