FDA Inspection 789469 — New Health Enterprise, Inc.
The FDA completed an inspection of New Health Enterprise, Inc. on Jul 10, 2012 in Tustin, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 10, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15669 | 21 CFR 111.310(c) | Laboratory facilities - dietary supplement specifications |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 15965 | 21 CFR 111.117 | Quality control operations - equipment, instruments, control |