# FDA 483 - Lions Medical Eye Bank & Research Center of Eastern VA - February 16, 2023

Source: https://www.globalkeysolutions.net/records/483/lions-medical-eye-bank-research-center-of-eastern-va/e6a909e7-5b36-4416-8d1a-570da023a636

> FDA 483 for Lions Medical Eye Bank & Research Center of Eastern VA on February 16, 2023. 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: 2023-02-16
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Lions Medical Eye Bank & Research Center of Eastern VA revealed significant deficiencies across its operations. The firm failed to validate process changes, lacked established procedures for critical HCT/P manufacturing steps, and did not adequately investigate positive environmental monitoring cultures. Additionally, the facility did not maintain or calibrate equipment according to established procedures, indicating a broad lack of control over its HCT/P processing and quality systems.

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## Related Officers

- [Kenneth L. Smalls](https://www.globalkeysolutions.net/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)
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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/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64