FDA Inspection
New Life Generation, Inc.New Life Generation, Inc. – FDA Inspection, Aug 10, 2011
Record Details
This FDA Inspection record concerns New Life Generation, Inc., with an inspection on August 10, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- New Life Generation, Inc.
- Inspection Date
- August 10, 2011
- Product Type
- Biologics
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ID · f697f207-db8f-4f8d-8aab-8656823a17ea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 739932
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
12- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.320(b)Designated complaint file
- 21 CFR 1271.160(b)(3)Actions verified, short and long term solutions
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.200(a)Cleaned, sanitized per established schedules
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.60(c)(2)Records stating determination not completed
- 21 CFR 1271.180(a)Procedures to meet core CTGP
Showing 10 of 12 citations.
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Other FDA inspections of New Life Generation, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2012 | VAI | 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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