Company
United StatesClinical Laboratories of HI at Wilcox Mem Hospital (Lab), Lihue, HI – FDA Inspections
Inspection records and compliance data for Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) in Lihue, Hawaii. 2 FDA inspections on record, 2 Form 483s, last inspected May 09, 2025.
Company Profile
This profile covers Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) based in Lihue, Hawaii, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected March 14, 2019. Last inspected May 9, 2025.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Maintain and clean equipment1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 9, 2025 | Not classified | Biologics | 1274431 |
| March 14, 2019 | VAI | Biologics · Blood and Blood Products | 1082655 |
FDA documents
Form 483s (2)
People (2)
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Company Information
Name
Clinical Laboratories of HI at Wilcox Mem Hospital (Lab)
FEI Number
1000100792
Address
3420 Kuhio Hwy, Lihue, Hawaii 96766, United States
Country
United States
ID: d66777fc-05d8-4b19-8a00-6d0031d4b633