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FDA Inspection
•CorneaGen - Richmond•June 13, 2011

CorneaGen - Richmond – FDA Inspection, Jun 13, 2011

Record Details

This FDA Inspection record concerns CorneaGen - Richmond, with an inspection on June 13, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
CorneaGen - Richmond
Inspection Date
June 13, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 7fefc635-1cbd-4d8e-afec-d941322c6b37

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
729194
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

1
  1. 21 CFR 1271.55(d)(1)(i)Documentation of CD testing and labs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of CorneaGen - Richmond

3
DateClassificationOfficeProject area
May 31, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 12, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
February 12, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for CorneaGen - Richmond
  • FDA Inspection 1059878 - 2018-05-31
  • FDA Inspection 974353 - 2016-05-12
  • FDA Inspection 823345 - 2013-02-12

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