FDA Inspection
CellSure, L3CCellSure, L3C – FDA Inspection, Dec 8, 2023
Record Details
This FDA Inspection record concerns CellSure, L3C, with an inspection on December 8, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 2a9579b3-ecc6-4ac3-968f-41b2b44409af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224419
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
12- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.150Written distribution procedure
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.150Written distribution procedure
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Other FDA inspections of CellSure, L3C
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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