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FDA Inspection
•District 2-A1 Lions Eye Bank, Inc•June 18, 2018

District 2-A1 Lions Eye Bank, Inc – FDA Inspection, Jun 18, 2018

Record Details

This FDA Inspection record concerns District 2-A1 Lions Eye Bank, Inc, with an inspection on June 18, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
District 2-A1 Lions Eye Bank, Inc
Inspection Date
June 18, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Darla J. Christopher (FDA Associated Person)
View Company Profile

ID · 47889b45-7694-4aa5-9c04-6f04892647ae

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1056012
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of District 2-A1 Lions Eye Bank, Inc

3
DateClassificationOfficeProject area
July 18, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 21, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
September 16, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for District 2-A1 Lions Eye Bank, Inc
  • FDA Inspection 1211484 - 2023-07-18
  • FDA Inspection 845282 - 2013-08-21
  • FDA Inspection 745427 - 2011-09-16

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