FDA Inspection 1313104 — Total Life Changes
The FDA completed an inspection of Total Life Changes on April 17, 2026 in Ira, MI. 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
- April 17, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Ira, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 22862 | 21 CFR 111.105(i) | Quality control - required operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22911 | 21 CFR 111.535(b) | Make and keep records - returned dietary supplements |
| 22912 | 21 CFR 111.560(a) | Product complaint - qualified person review & investigate |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |