FDA Inspection 898325 — Sunset Natural Products Inc.
The FDA completed an inspection of Sunset Natural Products Inc. on September 30, 2014 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 30, 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 |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15462 | 21 CFR 111.20(d)(1)(iv) | Physical plant - temperature, humidity controls |
| 15465 | 21 CFR 111.20(d)(2) | Air blowing equipment |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15557 | 21 CFR 111.260(k) | Batch record - packaging, labeling |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 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 |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |