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FDA Inspection
•New Life Generation, Inc.•December 23, 2009

New Life Generation, Inc. – FDA Inspection, Dec 23, 2009

Record Details

This FDA Inspection record concerns New Life Generation, Inc., with an inspection on December 23, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
New Life Generation, Inc.
Inspection Date
December 23, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 2f28a889-4da8-4137-8700-6fe289b03c7a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
636071
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

5
  1. 21 CFR 1271.55(a)(3)Summary--records used to make determination
  2. 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
  3. 21 CFR 1271.265(d)Shipping conditions appropriate
  4. 21 CFR 1271.180(a)Procedures to meet core CTGP
  5. 21 CFR 1271.210(a)Use prior to verification

Full citation text and observation details available on the Dashboard.

Other FDA inspections of New Life Generation, Inc.

2
DateClassificationOfficeProject area
February 28, 2012VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
August 10, 2011OAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for New Life Generation, Inc.
  • FDA Inspection 769928 - 2012-02-28
  • FDA Inspection 739932 - 2011-08-10

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