FDA Inspection 1208208 — Clinical Laboratories Of Hawaii, LLP
The FDA completed an inspection of Clinical Laboratories Of Hawaii, LLP on Jun 15, 2023 in Honolulu, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18039 | 21 CFR 606.100(b)(22) | Control risk of bacterial contamination of platelets |
| 18051 | 21 CFR 606.145(c) | Tx service release of product, notification, ID |