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FDA Inspection
•Advanced Reproduction Institute, LLC•March 17, 2016

Advanced Reproduction Institute, LLC – FDA Inspection, Mar 17, 2016

Record Details

This FDA Inspection record concerns Advanced Reproduction Institute, LLC, with an inspection on March 17, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Advanced Reproduction Institute, LLC
Inspection Date
March 17, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 96b31a20-2b2c-4c9a-99d7-7d6db65e7221

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
963288
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

1
  1. 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Advanced Reproduction Institute, LLC

4
DateClassificationOfficeProject area
March 21, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 19, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 17, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 13, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Advanced Reproduction Institute, LLC
  • FDA Inspection 1049265 - 2018-03-21
  • FDA Inspection 856038 - 2013-11-19
  • FDA Inspection 759284 - 2011-11-17
  • FDA Inspection 718198 - 2011-04-13

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