483
Lions Medical Eye Bank & Research Center of Eastern VALions Medical Eye Bank & Research Center of Eastern VA – FDA 483, Feb 11, 2025
Record Details
The FDA inspected Lions Medical Eye Bank & Research Center of Eastern VA in Norfolk, VA, an HCT/P establishment. The inspection revealed two significant issues related to the processing and storage of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Specifically, the firm failed to monitor environmental conditions during processing and did not establish acceptable temperature limits for HCT/P storage, potentially compromising product safety.
- Inspection date
- February 11, 2025
- Product type
- biologics
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ID · afe386b8-2395-4c6b-ba36-b866f7dd6c2c
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