FDA Inspection
Vitalife, Inc.Vitalife, Inc. – FDA Inspection, Dec 28, 2011
Record Details
This FDA Inspection record concerns Vitalife, Inc., with an inspection on December 28, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalife, Inc.
- Inspection Date
- December 28, 2011
- Product Type
- Biologics
View Company Profile
ID · 8a566aec-e8b7-4772-b4e0-aca420edba49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 760626
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Vitalife, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 9, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 25, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Vitalife, Inc.
- FDA Inspection 1170934 - 2022-05-19
- FDA Inspection 1007186 - 2017-03-09
- FDA Inspection 986131 - 2016-08-25
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