FDA Inspection 1034593 — Nutriwell Nutrition
The FDA completed an inspection of Nutriwell Nutrition on December 12, 2017 in Santa Ana, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15770 | 21 CFR 111.420(a) | Repackaging, relabeling - quality control, approve |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |