FDA Inspection 796211 — Nutraceutical Evolution, Inc.
The FDA completed an inspection of Nutraceutical Evolution, Inc. on August 17, 2012 in Boca Raton, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 17, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component 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 |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16008 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |