FDA Inspection 1006379 — Basic Reset Inc.
The FDA completed an inspection of Basic Reset Inc. on March 27, 2017 in Madison, TN. 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
- March 27, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Madison, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15947 | 21 CFR 111.105(i) | Quality control - required operations product complaints |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |