FDA Inspection 1082655 — Clinical Laboratories Of HI At Wilcox Mem Hospital (Lab)
The FDA completed an inspection of Clinical Laboratories Of HI At Wilcox Mem Hospital (Lab) on Mar 14, 2019 in Lihue, HI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 14, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lihue, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |