FDA Inspection 1314166 — Herbalife International of America, Inc
The FDA completed an inspection of Herbalife International of America, Inc on April 24, 2026 in Winston Salem, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Winston Salem, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 15980 | 21 CFR 111.123(a)(4) | Quality control operations - material review, disposition decision |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22863 | 21 CFR 111.110 | Quality control - Laboratory control processes; production, process control |
| 22872 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |