FDA Inspection 1224419 — CellSure, L3C
The FDA completed an inspection of CellSure, L3C on Dec 8, 2023 in Salt Lake City, UT. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |