# FDA 483 - Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) - May 09, 2025

Source: https://www.keypedia.com/records/483/clinical-laboratories-of-hi-at-wilcox-mem-hospital-lab/710dd3fd-cae2-4c24-91e7-2da0f6b79d28

> FDA 483 for Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) on May 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clinical Laboratories of HI at Wilcox Mem Hospital (Lab)
- Inspection Date: 2025-05-09
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Clinical Laboratories of Hawaii at Wilcox Medical Center in Lihue, Hawaii, a blood bank, identified two observations. The firm failed to maintain equipment used in blood processing, specifically a blood irradiator, lacking complete maintenance logs for 2024 and 2025. Additionally, the firm failed to maintain storage and distribution records, with numerous emergency release records missing required physician signatures.

## Related Documents

- [483 - 2019-03-14](https://www.keypedia.com/records/483/clinical-laboratories-of-hi-at-wilcox-mem-hospital-lab/4b6405a5-a94e-416b-9b19-a8f1444349c4)

## Related Officers

- [Eric Zhu](https://www.keypedia.com/people/eric-zhu/32919a8f-841a-441b-a489-8495f2e16993)

Company: https://www.keypedia.com/companies/clinical-laboratories-of-hi-at-wilcox-mem-hospital-lab/d66777fc-05d8-4b19-8a00-6d0031d4b633

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b