FDA Inspection
New Life Generation, Inc.New Life Generation, Inc. – FDA Inspection, Feb 28, 2012
Record Details
This FDA Inspection record concerns New Life Generation, Inc., with an inspection on February 28, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- New Life Generation, Inc.
- Inspection Date
- February 28, 2012
- Product Type
- Biologics
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ID · fa48eca7-0df8-452b-aaec-061daf23450c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769928
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.265(f)Return to inventory--procedures
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Other FDA inspections of New Life Generation, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2011 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 23, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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