FDA Inspection
Clinical Laboratories of Hawaii, LLPClinical Laboratories of Hawaii, LLP – FDA Inspection, Jun 15, 2023
Record Details
This FDA Inspection record concerns Clinical Laboratories of Hawaii, LLP, with an inspection on June 15, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b4f6cf8c-e378-4dc5-9705-6a90720869d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208208
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 606.145(c)Tx service release of product, notification, ID
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)(22)Control risk of bacterial contamination of platelets
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)(22)Control risk of bacterial contamination of platelets
- 21 CFR 606.145(c)Tx service release of product, notification, ID
- 21 CFR 606.160(a)(1)Concurrent documentation
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Other FDA inspections of Clinical Laboratories of Hawaii, LLP
12| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 12, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 16, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 18, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Clinical Laboratories of Hawaii, LLP
- FDA Inspection 1280587 - 2025-08-21
- FDA Inspection 1279652 - 2025-08-12
- FDA Inspection 1055322 - 2018-05-17
- FDA Inspection 1053641 - 2018-05-16
- FDA Inspection 1051026 - 2018-04-18
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