# FDA 483 - Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) - March 14, 2019

Source: https://www.keypedia.com/records/483/clinical-laboratories-of-hi-at-wilcox-mem-hospital-lab/4b6405a5-a94e-416b-9b19-a8f1444349c4

> FDA 483 for Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) on March 14, 2019. 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: 2019-03-14
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) in Lihue, HI, a hospital blood bank, was cited for two observations during an FDA inspection. The inspection revealed failures to consistently follow written standard operating procedures for blood processing and compatibility testing, including issues with SOP review and QC record documentation. Additionally, the firm failed to maintain equipment used in blood processing, specifically lacking records for required irradiator inspections.

## Related Officers

- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

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/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0