# FDA 483 - Lions Medical Eye Bank & Research Center of Eastern VA - February 11, 2025

Source: https://www.globalkeysolutions.net/records/483/lions-medical-eye-bank-research-center-of-eastern-va/afe386b8-2395-4c6b-ba36-b866f7dd6c2c

> FDA 483 for Lions Medical Eye Bank & Research Center of Eastern VA on February 11, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lions Medical Eye Bank & Research Center of Eastern VA
- Inspection Date: 2025-02-11
- Product Type: biologics
- Office Name: Baltimore District Office
- Summary: 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.

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## Related Officers

- [Kenneth P Gmalia](https://www.globalkeysolutions.net/people/kenneth-p-gmalia/425624bc-9202-45b7-b6fd-cdfb692578f7)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/chanel-e-crawford/9bad6899-4c17-405f-babb-554cee8d09e7)
- [Amy A. Johnson](https://www.globalkeysolutions.net/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)
- [Kenneth L. Smalls](https://www.globalkeysolutions.net/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)

Company: https://www.globalkeysolutions.net/companies/lions-medical-eye-bank-research-center-of-eastern-va/4b6c42ab-d99b-4da7-bb4c-d214fc3dcfa6

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa