FDA Inspection 1255850 — Vivant Skin Care, LLC
The FDA completed an inspection of Vivant Skin Care, LLC on December 5, 2024 in Miami Lakes, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 5, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |