FDA Inspection
LifeGiftLifeGift – FDA Inspection, Nov 16, 2009
Record Details
This FDA Inspection record concerns LifeGift, with an inspection on November 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- LifeGift
- Inspection Date
- November 16, 2009
- Product Type
- Biologics
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ID · a4f60275-c32a-4f83-be29-acb213631158
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628955
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.200(a)Capable of valid results
- 21 CFR 1271.260(b)Storage temperatures appropriate
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.200(b)Procedures inadequate
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