FDA Inspection 752395 — New Generation Wellness Inc.
The FDA completed an inspection of New Generation Wellness Inc. on Oct 25, 2011 in Colorado Springs, CO. 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). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 25, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15391 | 21 CFR 111.10(b)(3) | Hand washing |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |