FDA Inspection 1030853 — Basic Reset Inc.
The FDA completed an inspection of Basic Reset Inc. on November 7, 2017 in Madison, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 7, 2017
- Fiscal Year
- 2018
- 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 |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15613 | 21 CFR 111.165(e) | Product received - mix-ups |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |