FDA Inspection 1232040 — Leiluna, LLC
The FDA completed an inspection of Leiluna, LLC on Jan 17, 2025 in Tampa, FL. 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
- Jan 17, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22885 | 21 CFR 111.205(a) | Master manufacturing record - followed |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22912 | 21 CFR 111.560(a) | Product complaint - qualified person review & investigate |