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FDA Inspection
•Lions Eye Bank Of Nebraska•November 16, 2009

Lions Eye Bank Of Nebraska – FDA Inspection, Nov 16, 2009

Record Details

This FDA Inspection record concerns Lions Eye Bank Of Nebraska, with an inspection on November 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Lions Eye Bank Of Nebraska
Inspection Date
November 16, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 352a5c6f-0d3b-44d2-8ecb-0a5ea53304d6

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
629165
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

4
  1. 21 CFR 1271.265(d)Shipping conditions appropriate
  2. 21 CFR 1271.170(c)Trained or re-trained as necessary
  3. 21 CFR 1271.180(a)Procedures to meet core CTGP
  4. 21 CFR 1271.225Approval and timely communication

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Lions Eye Bank Of Nebraska

6
DateClassificationOfficeProject area
February 21, 2024NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 13, 2021NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 11, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 7, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 14, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for Lions Eye Bank Of Nebraska
  • FDA Inspection 1232999 - 2024-02-21
  • FDA Inspection 1158725 - 2021-12-13
  • FDA Inspection 1077767 - 2018-12-11
  • FDA Inspection 992548 - 2016-11-07
  • FDA Inspection 904119 - 2014-11-14

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