FDA Inspection
Clinical Laboratories of HI at Wilcox Mem Hospital (Lab)Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) – FDA Inspection, Mar 14, 2019
Record Details
This FDA Inspection record concerns Clinical Laboratories of HI at Wilcox Mem Hospital (Lab), with an inspection on March 14, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 14, 2019
- Product Type
- Biologics
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ID · a2669f19-e480-4109-9ace-e22eefa47200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082655
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Clinical Laboratories of HI at Wilcox Mem Hospital (Lab)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2025 | Not classified | San Francisco District Office |
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