FDA Inspection
LifeSource Cryobank, LLCLifeSource Cryobank, LLC – FDA Inspection, Mar 31, 2011
Record Details
This FDA Inspection record concerns LifeSource Cryobank, LLC, with an inspection on March 31, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- LifeSource Cryobank, LLC
- Inspection Date
- March 31, 2011
- Product Type
- Biologics
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ID · c8b2f5ec-2c21-45f0-bcbc-d5eaeaf3fdf7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 719414
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.210(d)(3)Lot documentation maintained
- 21 CFR 1271.90(c)(1)Autologous use only--labeling
- 21 CFR 1271.260(c)Expiration date factors
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.250(a)Controlling the labeling of HCT/Ps
- 21 CFR 1240.65Lack of permit
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Other FDA inspections of LifeSource Cryobank, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2008 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for LifeSource Cryobank, LLC
- FDA Inspection 551976 - 2008-12-10
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