FDA Inspection 1147632 — CellSure, L3C
The FDA completed an inspection of CellSure, L3C on August 2, 2021 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12255 | 21 CFR 1271.60(c) | Shipped but not kept in quarantine |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 17822 | 21 CFR 212.50(b)(7) | Complete instructions, procedures, specs |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |