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483
•Lions Eye Bank For Long Island•August 3, 2023

Lions Eye Bank For Long Island – FDA 483, Aug 3, 2023

Record Details

The FDA inspected Lions Eye Bank For Long Island, an ocular tissue bank in Valley Stream, NY, and observed significant deficiencies. The inspection revealed failures in maintaining an adequate tracking system for HCT/Ps, including issues with electronic inventory records and standard operating procedures. Additionally, the firm failed to maintain records concurrently with each step and exhibited inaccuracies and legibility problems in tissue return documentation.

Company
Lions Eye Bank For Long Island
Inspection date
August 3, 2023
Product type
biologics
Office
Division of Human and Animal Food Operations - East I
Person
  • Irina Gaberman (Investigator)
View Company Profile

ID · d682839e-b30e-438f-a1d5-5a520bca91d7

Violation Codes1
21 U.S.C. 374(b)

Full citation text and observation details available on the Dashboard.

Other documents for Lions Eye Bank For Long Island
  • 483 - 2020-09-04September 4, 2020

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