FDA Inspection 1262608 — Malibu Wellness Inc
The FDA completed an inspection of Malibu Wellness Inc on Feb 28, 2025 in Indianapolis, IN. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 28, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22851 | 21 CFR 111.75(b) | Specifications met, in-process - quality finished batch |
| 22867 | 21 CFR 111.140(b)(1) | Quality control operations; written procedures; material review, disposition |