FDA Inspection 630177 — Nutraceutical Evolution, Inc.
The FDA completed an inspection of Nutraceutical Evolution, Inc. on November 16, 2009 in Boca Raton, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 21 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 16, 2009
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15518 | 21 CFR 111.27(d)(4) | Contact surfaces - not in direct contact - cleaning |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15648 | 21 CFR 111.465(a)(2) | Hold - reserve sample; closure system |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15689 | 21 CFR 111.315(b)(3) | Sampling plans; finished batches |
| 15693 | 21 CFR 111.315(b)(1) | Laboratory control processes - sampling plans; labeling |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15755 | 21 CFR 111.205(c) | Master manufacturing record: readily available |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16025 | 21 CFR 111.140(b)(3)(vii) | material review, disposition, follow-up; signature |
| 16053 | 21 CFR 111.535(a) | Records - returned dietary supplement: 1 year, 2 years |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |