FDA Inspection
Clinical Laboratories of Hawaii, LLPClinical Laboratories of Hawaii, LLP – FDA Inspection, May 16, 2018
Record Details
This FDA Inspection record concerns Clinical Laboratories of Hawaii, LLP, with an inspection on May 16, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 9b1516d2-9506-48a5-b874-707afd2cb7c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053641
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| June 15, 2023 | VAI | 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 |
| April 18, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Clinical Laboratories of Hawaii, LLP
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- FDA Inspection 1279652 - 2025-08-12
- FDA Inspection 1208208 - 2023-06-15
- FDA Inspection 1055322 - 2018-05-17
- FDA Inspection 1051026 - 2018-04-18
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