FDA Inspection
CellSure, L3CCellSure, L3C – FDA Inspection, Aug 2, 2021
Record Details
This FDA Inspection record concerns CellSure, L3C, with an inspection on August 2, 2021, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CellSure, L3C
- Inspection Date
- August 2, 2021
- Product Type
- Biologics
View Company Profile
ID · 51e24b0d-7a09-4c20-890c-0239cbe803e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147632
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.60(c)Shipped but not kept in quarantine
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 1271.55(b)(3)Name and address on summary
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 212.50(b)(7)Complete instructions, procedures, specs
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Other FDA inspections of CellSure, L3C
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2023 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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