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FDA Inspection
•Lions Medical Eye Bank & Research Center of Eastern VA•February 11, 2025

Lions Medical Eye Bank & Research Center of Eastern VA – FDA Inspection, Feb 11, 2025

Record Details

This FDA Inspection record concerns Lions Medical Eye Bank & Research Center of Eastern VA, with an inspection on February 11, 2025, issued by the Baltimore District Office, covering biologics.

Company
Lions Medical Eye Bank & Research Center of Eastern VA
Inspection Date
February 11, 2025
Product Type
Biologics
Office
Baltimore District Office
People
  • Amy A. Johnson (Issuing Officer)
  • Chanel E. Crawford (FDA Personnel)
  • Kenneth L. Smalls (Issuing Officer)
  • Kenneth P Gmalia (Issuing Officer)
View Company Profile

ID · 360bf271-fbae-4d5f-8634-7c2035618d42

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1260767
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

2
  1. 21 CFR 1271.260(e)Temperature limits
  2. 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Lions Medical Eye Bank & Research Center of Eastern VA

7
DateClassificationOfficeProject area
February 16, 2023VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
November 15, 2019NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
October 27, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
January 22, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
July 28, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 7 other inspections on the company page
Other documents for Lions Medical Eye Bank & Research Center of Eastern VA
  • FDA Inspection 1197940 - 2023-02-16
  • FDA Inspection 1112314 - 2019-11-15
  • FDA Inspection 1031841 - 2017-10-27
  • FDA Inspection 960003 - 2016-01-22
  • FDA Inspection 889183 - 2014-07-28

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