Company
United StatesClinical Laboratories of Hawaii, LLP, Honolulu, HI – FDA Inspections
Inspection records and compliance data for Clinical Laboratories of Hawaii, LLP in Honolulu, Hawaii. 13 FDA inspections on record, 2 Form 483s, last inspected August 21, 2025.
Company Profile
This profile covers Clinical Laboratories of Hawaii, LLP based in Honolulu, Hawaii, United States.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 0
- VAI
- 3
- NAI
- 10
- Form 483s
- 2
- Warning letters
- 0
First inspected July 7, 2009. Last inspected August 21, 2025.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Biological product deviation report1 inspection
- Concurrent documentation1 inspection
FDA inspections (13)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 21, 2025 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1280587 |
| August 12, 2025 | NAI | Biologics · Blood and Blood Products | 1279652 |
| June 15, 2023 | VAI | Biologics · Blood and Blood Products | 1208208 |
| May 17, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1055322 |
| May 16, 2018 | VAI | Biologics · Blood and Blood Products | 1053641 |
| April 18, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1051026 |
| August 25, 2016 | NAI | Biologics · Blood and Blood Products | 981923 |
| June 9, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 973796 |
| October 30, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 853659 |
| August 20, 2013 | NAI | Biologics · Blood and Blood Products | 845287 |
| July 28, 2011 | VAI | Biologics · Blood and Blood Products | 740872 |
| July 9, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 597427 |
| July 7, 2009 | NAI | Biologics · Blood and Blood Products | 596882 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Inova Schar Cancer Institute
VA Portland Healthcare System
North Shore University Hospital Northwell Health
Geisinger Medical Center Blood Bank
Bloodworks
Creative Testing Solutions
DCI Donor Services Tissue Bank
Emory University Hospital Midtown- Center for Transfusion & Cellular Therapies
The American National Red Cross
Institute for Reproductive Health
Company Information
Name
Clinical Laboratories of Hawaii, LLP
FEI Number
2972911
Address
Kapiolani Medcl Ctr For Women & Children, 1319 Punahou St, Honolulu, Hawaii 96826, United States
Country
United States
ID: 6f4d1ccb-820a-4dcc-b5c1-f15daa7030c2